Breast pump system

ABSTRACT

The invention is a wearable breast pump system including a housing shaped at least in part to fit inside a bra and a piezo air-pump. The piezo air-pump is fitted in the housing and forms part of a closed loop system that drives a separate, deformable diaphragm to generate negative air pressure. The diaphragm is removably mounted on a breast shield.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. application Ser. No. 17/181,057, filed onFeb. 22, 2021, which is a U.S. application Ser. No. 16/009,547, filed onJun. 15, 2018, which is based on, and claims priority to, GB ApplicationNo. 1709561.3, filed Jun. 15, 2017; GB Application No. 1709564.7, filedon Jun. 15, 2017; GB Application No. 1709566.2, filed on Jun. 15, 2017;and GB Application No. 1809036.5, filed on Jun. 1, 2018, the entirecontents of each of which being fully incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The field of the invention relates to a breast pump system; oneimplementation of the system is a wearable, electrically powered breastpump system for extracting milk from a mother.

A portion of the disclosure of this patent document contains material,which is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent file or records, but otherwise reserves all copyrightrights whatsoever.

2. Description of the Prior Art

The specification of the present disclosure is broad and deep. We willnow describe the prior art in relation to key aspects of the presentdisclosure.

Prior Art Related to Breast Pump Systems

A breast pump system is a mechanical or electro-mechanical device thatextracts milk from the breasts of a lactating woman.

A typical breast pump design is as shown in WO 96/25187 A1. A largesuction generating device is provided, which is freestanding. This isattached by air lines to one or two breast shields which engage with theuser's breasts. A pressure cycle is applied from the suction generatingdevice, via the air lines, to the breast shields. This generates apressure cycle on the user's breasts to simulate the suction generatedby a feeding child.

The suction generating device is a large component that connects tomains power to operate the pumps therein. Milk collection bottles areprovided to store the expressed breast milk. In the system of WO96/36298 A1 separate bottles are provided attached to each breastshield. A single bottle with tubing connecting to each breast shield mayalso be used. But for a mother to use this discretely, such as in anoffice environment, specialised bras must be used. In particular,breast-pumping bras which have a central slit, for the nipple tunnel ofthe breast shield to extend through, are typically used. The breastshield is held within the bra, with the suction generating device andmilk bottle outside the bra.

The fundamental breast pump system has not significantly evolved fromthis approach, only minor technical improvements have been made.

However, these systems present a number of significant disadvantages. Asthe suction generating device is a large freestanding unit connected tomains power, the user may feel tethered to the wall. The known devicestypically also require a specific user posture and undressing tofunction normally. This is obviously difficult for a user to dodiscretely, such as in an office setting. The known devices are alsotypically noisy, uncomfortable, and hard to clean.

Fully integrated wearable breast pump systems have begun to enter themarket, such as described in US 2016 0206794 A1. In such pump systems,the suction source, power supply and milk container are contained in asingle, wearable device; there is no need for bulky external componentsor connections. Such devices can be provided with a substantially breastshaped convex profile so as to fit within a user's bra for discretepumping, as well as pumping on-the-go without any tethers to electricalsockets or collection stations. The internal breast shield is naturallyconvex to fit over a breast.

In US 2016 0206794 A1, when viewed from the front, the breast pumpdevice has a ‘tear-drop’ rounded shape, fuller at its base than at itstop. But it uses collapsible bags as milk collection devices. As thecollection bag systems are collapsible, it can be difficult for a userto extract all of their milk from the bag, due to the small cut openingthat is needed and the capillary action between the bonded plasticsheets that form the bag. This waste can be disheartening for the user,as this is food for their child. The bags are also not re-usable, so theuser is required to purchase and maintain a stock of these. As well aspresenting a recurring cost, if the user runs out of stock they areunable to use the product until more bags are purchased.

Furthermore, as a result of the collapsible bags, a complex and somewhatnoisy pumping arrangement is necessary. In particular, the breast shieldconnects to a tube which is provided with compression units which “step”the expressed milk through the tube to the collection bag. This uses thebreast milk as a hydraulic fluid to generate suction on the breast. Inorder to carry this out, a complex sequenced pulsing arrangement must beimplemented.

In addition to these systems being particularly complex and wasteful,only a relatively small bag can be used. In US 2016 206794,approximately 110 ml (4 fluid ounces) of milk can be collected beforethe bag must be changed. While this may be sufficient for some users,others may produce much more milk in a session.

A further integrated wearable breast pump system is shown in US 20130023821 A1. In the third embodiment in this document, the breast pumpsystem includes a motor driven vacuum pump and power source. An annular(or punctured disc) membrane is provided, with the flow path of the milkgoing through the centre of the annulus. The membrane is housed inseparate housing and is sealed at its inner and outer edges. The breastshield has a small protrusion to engage with these housing components.However, the design of this breast pump system results in a number ofproblems. The use of an annular membrane, with the fluid flow pathrunning through the opening of the annulus is undesirable as it resultsin a large and bulky device. There is therefore a need for improvedintegrated breast pump systems.

Prior Art Related to Liquid Measurement Systems

In the context of breast pump systems, it is useful to measure thequantity of expressed milk. One way to do this is to have a clearcontainer for the breast pump, through which the level of expressed milkinside the container can be seen. However, viewing the milk bottle isnot always possible, for example in a breast pump that collects milkwhile being worn inside a maternity bra.

An existing apparatus for detecting the level of liquid inside acontainer of a breast pump is that disclosed in US 2016/296681. In thisapparatus, a sensing mechanism is provided at the top of a container,which detects droplets of liquid, specifically breast milk, entering thecontainer. By detecting these droplets entering the container, theapparatus can determine the quantity of liquid which enters thecontainer. In this apparatus, an accurate indication of the level ofliquid in the container is reliant on the sensing mechanism being ableto accurately record every droplet entering the container.

Particularly at times when liquid enters the container at a high flowrate, this accuracy cannot be guaranteed, leading to significantcumulative errors. An accurate indication of the level of liquid in thecontainer in this apparatus is also reliant on the sensing mechanismalways being on during the pumping process, so that power consumption ofthe sensing mechanism is correspondingly high.

In view of the above, there is the need for an improved way to determinethe level of liquid inside a container connected to a breast pump.

Prior Art Related to Bra Clips

Many specialised bras (or brassieres) exist for maternity use and thatfacilitate nursing and/or breast pumping for milk collection, withoutthe need to remove the bra itself. In a traditional nursing bra, this isachieved with the use of an at least partially detachable cup, which canbe unhooked for feeding and/or pumping.

Further specialised bras are known which are provided with cut-outportions or slits which substantially align with the wearer's areola andnipple. Traditional breast pump systems comprise an elongate breastshield which extends away from the breast towards an external bottle andsource of suction. The breast shield is arranged to extend through thecut-out portion or slit, with the collection bottle and pumpingapparatus placed outside of the bra. These systems require the user toremove or unbutton any over-garments, and are uncomfortable when notpumping.

Integrated, wearable breast pump systems have begun to enter the market,such as previously noted US 2016 0206794 A1. In such pumps, the suctionsource, power supply and milk container are all in a single, wearabledevice, as noted above, without the need for bulky external componentsor connections. Such devices can be provided with a substantially breastshaped profile so as to fit within a user's bra for discrete pumping, aswell as pumping on-the-go without any tethers to electrical sockets orcollection stations.

Maternity (or nursing) bras such as disclosed in U.S. Pat. No. 4,390,024A have partially detachable cups, with several hooks provided along thebra strap for attaching the cups to the strap. The cups can then beattached to different hooks in order to adjust the bra strap length.However, these attachment points are fixed. Additionally, this bra hasbeen designed to accommodate the change in breast size before and afterthe feeding/pumping process. It is not designed to accommodate a breastpump. Accordingly, there is a need for a better system to accommodateintegrated wearable breast pumps.

SUMMARY OF THE INVENTION

The invention is a wearable breast pump system including: a housingshaped at least in part to fit inside a bra; a piezo air-pump fitted inthe housing and forming part of a closed loop system that drives aseparate, deformable diaphragm to generate negative air pressure, thatdiaphragm being removably mounted on a breast shield.

BRIEF DESCRIPTION OF THE FIGURES

Aspects of the invention will now be described, by way of example(s),with reference to the following Figures, which each show features ofvarious implementations of the invention including optional featuresthat may be utilised:

FIG. 1 is a front view of an assembled breast pump system.

FIG. 2 is a rear view of the assembled breast pump system of FIG. 1.

FIG. 3 is a front view of a partially disassembled breast pump system.

FIG. 4 is a rear view of the partially disassembled breast pump systemof FIG. 3.

FIG. 5 is a front view of a further partially disassembled breast pumpsystem.

FIG. 6 is a rear view of the further partially disassembled breast pumpsystem of FIG. 5.

FIG. 7 is a front view of the breast pump system of FIG. 1, with theouter shell translucent for ease of explanation.

FIG. 8 is a further front view of the breast pump system of FIG. 1, withthe front of the outer shell removed for ease of explanation.

FIG. 9 is a schematic view of a nipple tunnel for a breast shield.

FIG. 10 is a schematic of a pneumatic system for a breast pump system.

FIG. 11 is a schematic of an alternative pneumatic system for a breastpump system.

FIG. 12 is a schematic of a further alternative pneumatic system for abreast pump system.

FIG. 13 is a graph depicting measured pressure in the breast pump systemof FIG. 12 over time.

FIG. 14 shows schematics for breast shield sizing and nipple alignment.

FIG. 15 shows a screenshot of an application running on a deviceconnected to the breast pump system.

FIG. 16 shows a screenshot of an application running on a deviceconnected to the breast pump system.

FIG. 17 shows a screenshot of an application running on a deviceconnected to the breast pump system.

FIG. 18 shows a screenshot of an application running on a deviceconnected to the breast pump system.

FIG. 19 shows a screenshot of an application running on a deviceconnected to the breast pump system.

FIG. 20 shows a screenshot of an application running on a connecteddevice.

FIG. 21 shows a screenshot of an application running on a connecteddevice.

FIG. 22 shows a screenshot of an application running on a connecteddevice.

FIG. 23 shows a screenshot of an application running on a connecteddevice.

FIG. 24 shows a screenshot of an application running on a connecteddevice.

FIG. 25 shows a screenshot of an application running on a connecteddevice.

FIG. 26 shows a diagram of a breast pump sensor network,

FIG. 27 shows a sectional view of a device being used to determine thelevel of liquid in a container;

FIG. 28 shows a sectional view of the device and the container from FIG.27 being used at a different orientation.

FIG. 29 shows a sectional view of the device and the container from FIG.27 being used whilst undergoing acceleration.

FIG. 30 shows a sectional view of the device from FIG. 27 being used aspart of a breast pump assembly.

FIG. 31 shows a sectional view of a device connected between a containerand its lid, and which is operable to determine the level of liquidinside the container.

FIG. 32 depicts a prior art design for a maternity bra;

FIG. 33 depicts a clip and clasp being fitted to a maternity bra.

FIG. 34 depicts an alternative clip for adjustment of a maternity bra.

FIG. 35 depicts the alternative clip of FIG. 34.

FIG. 36 depicts an alternative clip for adjustment of a maternity bra.

FIG. 37 depicts an alternative clip for adjustment of a maternity bra.

FIG. 38 depicts an alternative clip for adjustment of a maternity bra.

FIG. 39 depicts adjustment of the maternity bra of FIG. 37.

FIG. 40 shows a configuration with two piezo pumps mounted in series.

FIG. 41 shows a configuration of two piezo pumps mounted in parallel.

FIG. 42 shows a plot of the air pressure generated as a function of timeby two piezo pumps mounted in series and mounted in parallelrespectively.

FIG. 43 shows a plot of the air pressure generated as a function of timeby two piezo pumps mounted in a dual configuration.

FIG. 44 shows a figure of a pump including two piezo pumps in which eachpiezo pump is connected to a heat sink.

DETAILED DESCRIPTION

We will now describe an implementation of the invention, called theElvie™ pump, in the following sections:

Section A: The Elvie™ Breast Pump System

Section B: An IR System

Section C: A Bra Clip

Section D: Piezo Pumps and Wearable Devices

Section A: The Elvie™ Breast Pump System

1. Elvie™ Breast Pump System Overview

An implementation of the invention, called the Elvie™ pump, is a breastpump system that is, at least in part, wearable inside a bra. The breastpump system comprises a breast shield for engagement with the user'sbreast, a housing for receiving at least a portion of the breast shieldand a detachable rigid milk collection container attachable, in use, toa lower face of the housing and connected to the breast shield forcollecting milk expressed by the user, with a milk-flow pathway definedfrom an opening in the breast shield to the milk collection container.The housing inside also includes a pump for generating a negativepressure in the breast shield, as well as battery and controlelectronics Unlike other wearable breast pumps, the only parts of thesystem that come into contact with milk in normal use are the breastshield and the milk container; milk only flows through the breast shieldand then directly into the milk container. Milk does not flow throughany parts of the housing at all, for maximum hygiene and ease ofcleaning.

With reference to FIG. 1 and FIG. 2, the assembled breast pump system100 includes a housing 1 shaped to substantially fit inside a bra. Thehousing 1 includes one or more pumps and a rechargeable battery. Thebreast pump system includes two parts that are directly connected to thehousing 1: the breast shield 7 and a milk container 3. The breast shield7 and the milk container 3 are directly removable or attachable from thehousing 1 in normal use or during normal dis-assembly (most clearlyshown in FIG. 5). All other parts that are user-removable in normal useor during normal dis-assembly are attached to either the breast shield 7or the milk container 3. The breast shield 7 and milk container 3 may beremoved or attached for example using a one click or one press action ora push button or any other release mechanism. Audible and/or hapticfeedbacks confirm that the pump is properly assembled.

The modularity of the breast pump allows for easy assembly, disassemblyand replacement of different parts such as the breast shield and milkcollection container. This also allows for different parts of the pumpto be easily washed and/or sterilised. The breast shield and bottleassembly, both of which are in contact with milk during pumping, maytherefore be efficiently and easily cleaned; these are the only twoitems that need to be cleaned; in particular, the housing does not needto be cleaned.

The housing 1, breast shield 7 that is holding a flexible diaphragm, andmilk container 3 attach together to provide a closed-loop pneumaticsystem powered by piezoelectric pumps located in the housing 1. Thissystem then applies negative pressure directly to the nipple, forms anairtight seal around the areola, and provides a short path for expressedmilk to collect in an ergonomically shaped milk container 3.

The different parts of the breast shield system are also configured toautomatically self-seal under negative pressure for convenience ofassembly and disassembly and to reduce the risk of milk spillage.Self-sealing refers to the ability of sealing itself automatically orwithout the application of adhesive, glue, or moisture (such as forexample a self-sealing automobile tire or self-sealing envelopes). Henceonce the breast pump system is assembled it self-seals under itsassembled condition without the need to force seals into interferencefits to create sealed chambers. A degree of interference fitting isusual however, but is not the predominating attachment mechanism.Self-sealing enables simple components to be assembled together with alight push: for example the diaphragm just needs to be placed lightlyagainst the diaphragm housing; it will self-seal properly andsufficiently when the air-pump applies sufficient negative air-pressure.The diaphragm itself self-seals against the housing when the breastshield is pushed into the housing. Likewise, the breast shieldself-seals against the milk container when the milk container is pushedup to engage the housing. This leads to simple and fast assembly anddis-assembly, making it quick and easy to set the device up for use, andto clean the device after a session.

Self-sealing has a broad meaning and may also relate to any, wholly orpartly self-energising seals. It may also cover any interference seals,such as a press seal or a friction seal, which are achieved by frictionafter two parts are pushed together.

Whilst one particular embodiment of the invention's design and aspecific form of each of the parts of the breast pump system is detailedbelow, it can be appreciated that the overall description is notrestrictive, but an illustration of topology and function that thedesign will embody, whilst not necessary employing this exact form ornumber of discrete parts.

The breast pump system 100 comprises a housing 1 and a milk collectioncontainer (or bottle) 3. The housing 1 (including the one or more pumpsand a battery) and the container 3 are provided as a unit with a convexouter surface contoured to fit inside a bra. The milk collectioncontainer 3 is attached to a lower face 1A of the housing 1 and forms anintegral part of the housing when connected, such that it can be heldcomfortably inside a bra. While the breast pump 100 may be arranged tobe used with just the right or the left breast specifically, the breastpump 100 is preferably used with both breasts, without modification. Tothis end, the outer surfaces of the breast pump 100 are preferablysubstantially symmetrical.

Preferably, the width of the complete breast pump device (housing 1 andmilk container 3) is less than 110 mm and the height of the completebreast pump device is less than 180 mm.

Overall, the breast pump system 100 gives discrete and comfortable wearand use. The system weighs about 224 grams when the milk container isempty, making it relatively lighter as compared to current solutions;lightness has been a key design goal from the start, and has beenachieved through a lightweight piezo pump system and engineering designfocused on minimising the number of components.

The breast pump system 100 is small enough to be at least in part heldwithin any bra without the need to use a specialized bra, such as amaternity bra or a sports bra. The rear surface of the breast pump isalso concave so that it may sit comfortably against the breast. Theweight of the system has also been distributed to ensure that the breastpump is not top heavy, ensuring comfort and reliable suction against thebreast. The centre of gravity of the pump system is, when the containeris empty, substantially at or below the horizontal line that passesthrough the filling point on the breast shield, so that the device doesnot feel top-heavy to a person while using the pump.

Preferably, when the container is empty, the centre of gravity issubstantially at or below the half-way height line of the housing sothat the device does not feel top-heavy to a user using the pump.

The centre of gravity of the breast pump, as depicted by FIG. 1, is ataround 60 mm high on the centreline from the base of the breast pumpwhen the milk container is empty. During normal use, and as the milkcontainer gradually receives milk, the centre of gravity lowers, whichincreases the stability of the pump inside the bra. It reduces to around40 mm high on the centreline from the base of the breast pump when themilk container is full.

The centre of gravity of the breast pump is at about 5.85 mm below thecentre of the nipple tunnel when the milk container is empty, andreduced to about 23.60 mm below the centre of the nipple tunnel when themilk container is full. Generalizing, the centre of gravity should be atleast 2 mm below the centre of the nipple tunnel when the container isempty.

The breast pump 100 is further provided with a user interface 5. Thismay take the form of a touchscreen and/or physical buttons. Inparticular, this may include buttons, sliders, any form of display,lights, or any other componentry necessary to control and indicate useof the breast pump 100. Such functions might include turning the breastpump 100 on or off, specifying which breast is being pumped, increasingor decreasing the peak pump pressure. Alternatively, the informationprovided through the user interface 5 might also be conveyed throughhaptic feedback, such as device vibration, driven from a miniaturevibration motor within the pump housing 1.

In the particular embodiment of the Figures, the user interface 5comprises power button 5A for turning the pump on and off. The userinterface 5 further comprises pump up button 5B and pump down button 5C.These buttons adjust the pressure generated by the pump and hence thevacuum pressure applied to the user's breast. In preferable embodiments,the pump up button 5B could be physically larger than the pump downbutton 5C. A play/pause button 5D is provided for the user to interruptthe pumping process without turning the device off.

The user interface 5 further comprises a breast toggle button 5E for theuser to toggle a display of which breast is being pumped. This may beused for data collection, e.g. via an application running on a connectedsmartphone; the app sends data to a remote server, where data analysisis undertaken (as discussed in more detail later), or for the user tokeep track of which breast has most recently been pumped. In particular,there may be a pair of LEDs, one to the left of the toggle button 5E andone to the right. When the user is pumping the left breast, the LED tothe right of the toggle button 5E will illuminate, so that when the userlooks down at the toggle it is the rightmost LED from their point ofview that is illuminated. When the user then wishes to switch to theright breast, the toggle button can be pressed and the LED to the leftof the toggle button 5E, when the user looks down will illuminate. Theconnected application can automatically track and allocate how much milkhas been expressed, and when, by each breast.

The breast pump system also comprises an illuminated control panel, inwhich the level of illumination can be controlled at night or whenstipulated by the user. A day time mode, and a less bright night timemode that are suitable to the user, are available. The control of theillumination level is either implemented in hardware within the breastpump system itself or in software within a connected device applicationused in combination with the breast pump system.

As depicted in FIG. 1, the housing 1 and milk collection container 3form a substantially continuous outer surface, with a generally convexshape. This shape roughly conforms with the shape of a ‘tear-drop’shaped breast. This allows the breast pump 100 to substantially fitwithin the cup of a user's bra. The milk collection container 3 isretained in attachment with the housing 1 by means of a latch system,which is released by a one-click release mechanism such as a push button2 or any other one-handed release mechanism. An audible and/or hapticfeedback may also be used to confirm that the milk collection container3 has been properly assembled.

The European standard EN 13402 for Cup Sizing defines cup sizes basedupon the bust girth and the underbust girth of the wearer and rangesfrom AA to Z, with each letter increment denoting an additional 2 cmdifference. Some manufacturers do vary from these conventions indenomination, and some maternity bras are measured in sizes of S, M, L,XL, etc. In preferred embodiments, the breast pump 100 of the presentinvention corresponds to an increase of between 3 or 4 cup sizes of theuser according to EN 13402.

A plane-to-plane depth of the breast pump can also be defined. This isdefined as the distance between two parallel planes, the first of whichis aligned with the innermost point of the breast pump 100, and thesecond of which is aligned with the outermost point of the breast pump100. This distance is preferably less than 100 mm.

FIG. 2 is a rear view of the breast pump 100 of FIG. 1. The innersurface of the housing 1 and milk collection container 3 are shown,along with a breast shield 7. The housing 1, milk collection container 3and breast shield 7 form the three major subcomponents of the breastpump system 100. In use, these sub-components clip together to providethe functioning breast pump system 100. The breast shield 7 is designedto engage with the user's breast, and comprises a concave inner flange7A which contacts the breast. To allow the breast pump 100 to be used oneither of the user's breasts, the breast shield 7 is preferablysubstantially symmetrical on its inner flange 7A.

The inner flange 7A is substantially oval-shaped. While the inner flange7A is concave, it is relatively shallow such that it substantially fitsthe body form of the user's breast. In particular, when measured side-onthe inner-most point of the flange 7A and the outermost point may beseparated by less than 25 mm. By having a relatively shallow concavesurface, the forces applied can be spread out over more surface area ofthe breast. The flatter form also allows easier and more accuratelocation of the user's nipple. In particular, the flange 7A of thebreast shield 7 may extend over the majority of the inner surface of thehousing 1 and milk collection container 3. Preferably, it may extendover 80% of this surface. By covering the majority of the inner surface,the breast shield is the only component which contact's the wearer'sbreast. This leaves fewer surfaces which require thorough cleaning as itreduces the risk of milk contacting a part of the device which cannot beeasily sterilized. Additionally, this also helps to disperse thepressure applied to the user's breast across a larger area.

The breast shield 7 substantially aligns with the outer edge 1B of thehousing 1. The milk collection container 3 may be provided with anarcuate groove for receiving a lower part of the breast shield 7. Thisis best shown in later Figures. In the assembled arrangement of FIGS. 1and 2, the inner surface of the breast pump 100 is substantiallycontinuous.

The breast shield 7 comprises a shield flange for engaging the user'sbreast, and an elongate nipple tunnel 9) aligned with the opening andextending away from the user's breast. Breast shield nipple tunnel 9extends from a curved section 7B in the breast shield 7. In preferableembodiments the nipple tunnel 9 is integral with the breast shield 7.However, it is appreciated that separate removable/interchangeablenipple tunnels may be used. Curved section 7B is positioned over theuser's nipple and areola in use. The breast shield 7 forms an at leastpartial seal with the rest of the user's breast around this portion,under the negative air pressure created by an air-pressure pump.

This breast shield nipple tunnel 9 defines a milk-flow path from theinner surface of the breast shield 7A, through the breast shield nippletunnel 9 and into the milk collection container 3. The breast shieldnipple tunnel 9 is preferably quite short in order to minimise thelength of the milk-flow path in order to minimise losses. By reducingthe distance covered by the milk, the device is also reduced in size andcomplexity of small intermediate portions. In particular, the breastshield nipple tunnel 9 may extend less than 70 mm from its start to end,more preferably less than 50 mm. In use, the nipple tunnel 9 issubstantially aligned with the user's nipple and areolae. The nippletunnel comprises a first opening 9A for depositing milk into thecollection container and a second opening 19A for transferring negativeair pressure generated by the pump to the user's nipple.

The shield flange 7A and nipple tunnel 9 may be detachable from thehousing 1 together. The shield flange 7A and nipple tunnel 9 beingdetachable together helps further simplify the design, and reduce thenumber of components which must be removed for cleaning andsterilization. However, preferably, the nipple tunnel 9 will be integralwith the breast shield 7, in order to simplify the design and reduce thenumber of components which must be removed for cleaning andsterilisation.

FIGS. 3 and 4 are of a partially disassembled breast pump 100 of thepresent invention. In these Figures, the breast shield 7 has beendisengaged from the housing 1 and milk collection bottle 3. As shown inFIG. 4, the housing 1 comprises a region or slot 11 for receiving thebreast shield nipple tunnel 9 of the breast shield 7. The breast shieldis held in place thanks to a pair of channels (9B) included in thenipple tunnel 9, each channel including a small indent. When pushing thehousing 1 onto the breast shield 7, which has been placed over thebreast, ridges in the housing (9C) engage with the channels, guiding thehousing into position; a small, spring plunger, such as ball bearing ineach ridge facilitates movement of the housing on to the nipple tunnel9. The ball bearings locate into the indent to secure the housing on tothe nipple tunnel with a light clicking sound. In this way, the user canwith one hand place and position the breast shield 7 onto her breast andwith her other hand, position and secure the housing 1 on to the breastshield 7. The breast shield 7 can be readily separated from the housing1 since the ball bearing latch only lightly secures the breast shield 7to the housing 1.

Alternatively, the breast shield 7 may also be held in place by means ofa clip engaging with a slot located on the housing. The clip may beplaced at any suitable point on the shield 7, with the slot in acorresponding location.

The breast shield nipple tunnel 9 of the breast shield 7 is providedwith an opening 9A on its lower surface through which expressed milkflows. This opening 9A is configured to engage with the milk collectionbottle 3.

The breast pump 100 further comprises a barrier or diaphragm fortransferring the pressure from the pump to the milk-collection side ofthe system. In the depicted example, this includes flexible rubberdiaphragm 13 seated into diaphragm housing 19A. The barrier could be anyother suitable component such as a filter or an air transmissivematerial. Diaphragm housing 19A includes a small air hole into thenipple tunnel 9 to transfer negative air pressure into nipple tunnel 9and hence to impose a sucking action on the nipple placed in the nippletunnel 9.

Hence, the air pump acts on one side of the barrier or diaphragm 13 togenerate a negative air pressure on the opposite, milk-flow side of thebarrier. The barrier has an outer periphery or surface, i.e. the surfaceof diaphragm housing 19A that faces towards the breast, and themilk-flow pathway extends underneath the outer periphery or surface ofthe barrier or diaphragm housing 19A. The milk-flow path extending underthe outer periphery or surface of the barrier 19A allows for a simplerand more robust design, without the milk-flow pathway extending throughthe barrier. This provides increased interior space and functionalityfor the device.

As noted, the milk-flow pathway extends beneath or under the barrier 13or surface of diaphragm housing 19A. This provides an added benefit ofhaving gravity move the milk down and away from the barrier.

Preferably the milk-flow pathway does not pass through the barrier 32.This results in a simpler and smaller barrier design.

As noted, the diaphragm 13 is mounted on diaphragm housing 19A that isintegral to the breast shield. This further helps increase the ease ofcleaning and sterilisation as all of the components on the “milk” flowside can be removed.

The barrier 13 may also provide a seal to isolate the air pump from themilk-flow side of the barrier. This helps to avoid the milk becomingcontaminated from the airflow or pumping side (i.e. the non-milk-flowside).

Alternatively, the only seal is around an outer edge of the barrier 13.This is a simple design as only a single seal needs to be formed andmaintained. Having multiple seals, such as for an annular membrane,introduces additional complexity and potential failure points.

As illustrated in FIGS. 3 and 4, the barrier may include a flexiblediaphragm 13 formed by a continuous circular disc shaped membrane whichis devoid of any openings or holes. This provides a larger effective“working” area of the diaphragm (i.e. the area of the surface in contactwith the pneumatic gasses) than an annular membrane and hence themembrane may be smaller in diameter to have the same working area.

The diaphragm 13 is arranged so that the milk-flow pathway extends belowand past the outer surface or periphery of the diaphragm 13. This meansthat the milk-flow pathway does not extend through the diaphragm 13. Inparticular, the milk-flow pathway is beneath the diaphragm 13. However,the diaphragm 13 may be offset in any direction with respect to themilk-flow pathway, provided that the milk-flow pathway does not extendthrough the diaphragm 13.

Preferably, the diaphragm 13 is a continuous membrane, devoid of anyopenings. The diaphragm 13 is held in a diaphragm housing 19, which isformed in two parts. The first half 19A of the diaphragm housing 19 isprovided on the outer surface of the breast shield 7, above the breastshield nipple tunnel 9 and hence the milk-flow pathway. In preferredembodiments, the first half 19A of the diaphragm housing 19 is integralwith the breast shield. The second half 19B of the diaphragm housing isprovided in a recessed portion of the housing 1. The diaphragm 13self-seals in this diaphragm housing 19 around its outer edge, to form awatertight and airtight seal. Preferably, the self-seal around the outeredge of the diaphragm 13 is the only seal of the diaphragm 13. This isbeneficial over systems with annular diaphragms which must seal at aninner edge as well. Having the diaphragm 13 mounted in the breast pump100 in this manner ensures that it is easily accessible for cleaning andreplacement. It also ensures that the breast shield 7 and diaphragm 13are the only components which need to be removed from the pump 100 forcleaning. Because the diaphragm 13 self-seals under vacuum pressure, itis easily removed for cleaning when the device is turned off.

FIGS. 5 and 6 show a breast pump 100 according to the present inventionin a further disassembled state. In addition to the breast shield 7 anddiaphragm 13 being removed, the milk collection container 3 has beenunclipped. Preferably, the milk collection container 3 is asubstantially rigid component. This ensures that expressed milk does notget wasted, while also enhancing re-usability. In some embodiments, themilk collection container 3 may be formed of three sections: a frontbottle portion, a rear bottle portion, and a cap. These three sectionsmay clip together to form the milk collection container 3. Thisthree-part system is easy to empty, easily cleanable since it can bedis-assembled, and easily re-usable. The milk collection container ormilk bottle may be formed of at least two rigid sections which areconnectable. This allows simple cleaning of the container for re-use.Alternatively, the container may be a single container made using a blowmoulding construction, with a large opening to facilitate cleaning. Thislarge opening is then closed with a cap with an integral spout 35 or‘sealing plate’ (which is bayonet-mounted and hence more easily cleanedthan a threaded mount spout). A flexible rubber valve 37 (or ‘sealingplate seal’) is mounted onto the cap or spout 35 and includes a rubberduck-bill valve that stays sealed when there is negative air-pressurebeing applied by the air pump; this ensures that negative air-pressuredoes not need to be applied to the milk container and hence adds to theefficiency of the system. The flexible valve 37 self-seals againstopening 9A in nipple tunnel 9. Because it self-seals under vacuumpressure, it automatically releases when the system is off, making iteasy to remove the milk container.

Preferably, the milk collection container resides entirely below themilk flow path defined by the breast shield when the breast pump system100 is positioned for normal use, hence ensuring fast and reliable milkcollection.

The milk collection container 3 has a capacity of approximately 5 fluidounces (148 ml). Preferably, the milk collection container has a volumeof greater than 120 ml. More preferably, the milk collection containerhas a volume of greater than 140 ml. To achieve this, the milkcollection container 3 preferably has a depth in a direction extendingaway from the breast in use, of between 50 to 80 mm, more preferablybetween 60 mm to 70 mm, and most preferably between 65 mm to 68 mm.

The milk collection container 3 further preferably has a height,extending in the direction from the bottom of the container 3 in use tothe cap or spout or sealing plate 35, of between 40 mm to 60 mm, morepreferably between 45 mm to 55 mm, and most preferably between 48 mm to52 mm. The cap 35 may screw into the milk collection bottle 3. Inparticular, it may be provided with a threaded connection or a bayonetand slot arrangement.

Further preferably, the milk collection container has a length,extending from the leftmost point to the rightmost point of thecontainer 3 in use, of between 100 mm to 120 30 mm, more preferablybetween 105 mm to 115 mm, and most preferably between 107 mm to 110 mm.

This cap 35 is provided with a one-way valve 37, through which milk canflow only into the bottle. This valve 37 prevents milk from spillingfrom the bottle once it has been collected. In addition, the valve 37automatically seals completely unless engaged to the breast shield 7.This ensures that when the pump 100 is dismantled immediately afterpumping, no milk is lost from the collection bottle 3. It can beappreciated that this one-way valve 37 might also be placed on thebreast shield 7 rather than in this bottle cap 35.

Alternatively, the milk bottle 3 may form a single integral part with acap 35. Cap 35 may include an integral milk pouring spout.

In certain embodiments, a teat may be provided to attach to the annularprotrusion 31A or attach to the spout that is integral with cap 35, toallow the container 3 to be used directly as a bottle. This allows themilk container to be used directly as a drinking vessel for a child. Themilk collection container may also be shaped with broad shoulders suchthat it can be adapted as a drinking bottle that a baby can easily hold.

Alternatively, or in addition, a spout may be provided to attach to theprotrusion 31A for ease of pouring. A cap may also be provided to attachto the protrusion 31A in order to seal the milk collection bottle 3 foreasy storage.

The pouring spout, drinking spout, teat or cap may also be integral tothe milk collection container.

Further, the removable milk collection container or bottle includes aclear or transparent wall or section to show the amount of milkcollected. Additionally, measurement markings (3A) may also be presenton the surface of the container. This allows the level of milk withinthe container to be easily observed, even while pumping. The milkcollection container or bottle may for example be made using anoptically clear, dishwasher safe polycarbonate material such as Tritan™.

The milk collection container or bottle may include a memory or aremovable tag, such as a tag including an NFC chip, that is programmedto store the date and time it was filled with milk, using data from thebreast pump system or a connected device such as a smartphone. Thecontainer therefore includes wireless connectivity and connects to acompanion app. The companion app then tracks the status of multiple milkcollection containers or bottles to select an appropriate container orbottle for feeding. The tag of the bottle may also be programmed tostore the expiry date of the milk as well as the quantity of the milkstored.

FIGS. 7 and 8 show front views of a breast pump system 100. Theouter-surface of the housing 1 has been drawn translucent to show thecomponents inside. The control circuitry 71 for the breast pump 100 isshown in these figures. The control circuitry in the present embodimentcomprises four separate printed circuit boards, but it is appreciatedthat any other suitable arrangement may be used.

The control circuitry may include sensing apparatus for determining thelevel of milk in the container 3. The control circuitry may furthercomprise a wireless transmission device for communicating over awireless protocol (such as Bluetooth) with an external device. This maybe the user's phone, and information about the pumping may be sent tothis device. In embodiments where the user interface comprises a breasttoggle button 5E, information on which breast has been selected by theuser may also be transmitted with the pumping information. This allowsthe external device to separately track and record pumping and milkexpression data for the left and right breasts.

There should also be a power charging means within the control circuitry71 for charging the battery 81. While an external socket, cable orcontact point may be required for charging, a form of wireless chargingmay instead be used such as inductive or resonance charging. In theFigures, charging port 6 is shown for charging the battery 81. This port6 may be located anywhere appropriate on the housing 1.

FIG. 8 shows the location of the battery 81 and the pumps 83A, 83Bmounted in series inside the housing 1. While the depicted embodimentshows two pumps 83A, 83B it is appreciated that the present inventionmay have a single pump. Preferably, an air filter 86 is provided at theoutput to the pumps 83A, 83B. In preferable embodiments, the pumps 83A,83B are piezoelectric air pumps (or piezo pumps), which operate nearlysilently and with minimal vibrations. A suitable piezo pump ismanufactured by TTP Ventus, which can deliver in excess of 400 mBar (40kPa) stall pressure and 1.5 litres per minute free flow. The rear sideof the second half of the diaphragm housing 19B in the housing 1 isprovided with a pneumatic connection spout. The pumps 83A, 83B arepneumatically connected with this connection spout.

Operation of the breast pump 100 will now be described. Once the breastpump 100 is activated and a pumping cycle is begun, the pumps 83A, 83Bgenerates a negative air pressure which is transmitted via an airchannel to a first side of the diaphragm 13 mounted on the diaphragmhousing 19A. This side of the diaphragm 13 is denoted the pumping side13B of the diaphragm 13.

The diaphragm 13 transmits this negative air pressure to its oppositeside (denoted the milk-flow side 13A). This negative pressure istransferred through a small opening in the diaphragm housing 19A to thebreast shield nipple tunnel 9 and the curved opening 7B of the breastshield 7 that contacts the breast. This acts to apply the pressure cycleto the breast of the user, in order to express milk. The milk is thendrawn through the nipple tunnel 9, to the one way valve 37 that remainsclosed whilst negative pressure is applied. When the negative airpressure is released, the valve 37 opens and milk flows under gravitypast the valve 37 and into milk container 3. Negative air pressure isperiodically (e.g. cyclically, every few seconds) applied to deliverpre-set pressure profiles such as profiles that imitate the sucking of achild.

While the depicted embodiment of the breast pump 100 is provided withtwo pumps, the following schematics will be described with a single pump83. It is understood that the single pump 83 could be replaced by twoseparate piezo air-pumps 83A, 83B as above.

FIG. 9 depicts a schematic of a further embodiment of a breast shieldnipple tunnel 9 for a breast pump 100. The breast shield nipple tunnel 9is provided with an antechamber 91 and a separation chamber 93. Aprotrusion 95 extends from the walls of the breast shield nipple tunnel9 to provide a tortuous air-liquid labyrinth path through the breastshield nipple tunnel 9. In the separation chamber 93 there are twoopening 97, 99. An air opening 97 is provided in an upper surface 93A ofthe separation chamber 93. This upper surface 93 is provided transverseto the direction of the breast shield nipple tunnel 9. This opening 97connects to the first side of the diaphragm housing 19A and is thesource of the negative pressure. This airflow opening 97 also provides aroute for air to flow as shown with arrow 96. It is appreciated that thetortuous pathway is not necessary and that a breast shield nipple tunnel9 without such a pathway will work.

The other opening 99 is a milk opening 99. The milk opening 99 isprovided on a lower surface 93B of the separation chamber 93 andconnects in use to the container 3. After flowing through the tortuousbreast shield nipple tunnel 9 pathway, the milk is encouraged to flowthrough this opening 99 into the container 3. This is further aided bythe transverse nature of the upper surface 93A. In this manner,expressed milk is kept away from the diaphragm 13. As such, the breastpump 100 can be separated into a “air” side comprising the pump 83, theconnection spout 85 and the pumping side 13B of the diaphragm 13 and a“milk-flow” side comprising the breast shield 7, the milk collectioncontainer 3 and the milk-flow side 13A of the diaphragm 13. This ensuresthat all of the “milk-flow” components are easily detachable forcleaning, maintenance and replacement. Additionally, the milk is keptclean by ensuring it does not contact the mechanical components. Whilethe present embodiment discusses the generation of negative pressurewith the pump 83, it will be appreciated that positive pressure mayinstead be generated.

While the embodiments described herein use a diaphragm 13, any suitablestructure to transmit air pressure while isolating either side of thesystem may be used.

The breast pump may further comprise a pressure sensor in pneumaticconnection with the piezo pump. This allows the output of the pump to bedetermined.

FIG. 10 shows a schematic of a basic pneumatic system 200 for a breastpump 100. In the system 200 milk expressed into the breast shield 7 isdirected through the breast shield nipple tunnel 9 through the torturousair-liquid labyrinth interface 95. The milk is directed through thenon-return valve 37 to the collection container 3. This side of thesystem forms the “milk-flow” side 201.

The rest of the pneumatic system 200 forms the air side 202 and isseparated from contact with milk. This is achieved by way of a flexiblediaphragm 13 which forms a seal between the two sides of the system. Thediaphragm 13 has a milk-flow side 13A and an air side or pumping side13B.

The air side 202 of the system 200 is a closed system. This air side 202may contain a pressure sensor 101 in pneumatic connection with thediaphragm 13 and the pump 83. Preferably, the pump 83 is a piezoelectricpump (or piezo pump). Due to their low noise, strength and compact size,piezoelectric pumps are ideally suited to the embodiment of a small,wearable breast pump. The pump 83 has an output 83A for generatingpressure, and an exhaust to the atmosphere 83B. In a first phase of theexpression cycle, the pump 83 gradually applies negative pressure tohalf of the closed system 202 behind the diaphragm 13. This causes thediaphragm 13 to extend away from the breast, and thus the diaphragm 13conveys a decrease in pressure into the breast shield 7. The reducedpressure encourages milk expression from the breast, which is directedthrough the tortuous labyrinth system 95 and the one-way valve 37 to thecollection bottle 3.

While in the depicted embodiment the air exhaust 83B is not used, it maybe used for functions including, but not limited to, cooling ofelectrical components, inflation of the bottle to determine milk volume(discussed further later) or inflation of a massage bladder or lineragainst the breast. This massage bladder may be used to helpmechanically encourage milk expression. More than one massage bladdermay be inflated regularly or sequentially to massage one or more partsof the breast. Alternatively, the air pump may be used to provide warmair to one or more chambers configured to apply warmth to one or moreparts of the breast to encourage let-down.

The air side 202 further comprises a two-way solenoid valve 103connected to a filtered air inlet 105 and the pump 83. Alternatively,the filter could be fitted on the pump line 83A. If the filter is fittedhere, all intake air is filtered but the performance of the pump maydrop. After the negative pressure has been applied to the user's breast,air is bled into the system 202 through the valve 103 in a second phaseof the expression cycle. In this embodiment, the air filter 105 isaffixed to this inlet to protect the delicate components fromdegradation. In particular, in embodiments with piezoelectriccomponents, these are particularly sensitive.

The second phase of the expression cycle and associated switching ofvalve 103 is actioned once a predefined pressure threshold has beenreached. The pressure is detected by a pressure sensor 101.

In certain embodiments, if the elasticity and extension of the diaphragm13 may be approximated mathematically at different pressures, thepressure measured by sensor 101 can be used to infer the pressuresexposed to the nipple on the opposite side of the diaphragm 13. FIG. 11shows an alternative pneumatic system 300. The core architecture of thissystem is the same as the system shown in FIG. 10.

In this system 300, the closed loop 202 is restricted with an additionalthree way solenoid valve 111. This valve 111 allows the diaphragm 13 tobe selectively isolated from the rest of the closed loop 202. Thisadditional three way valve 111 is located between the diaphragm 13 andthe pump 83. The pressure sensor 101 is on the pump 83 side of the threeway valve 111. The three way valve 111 is a single pole double throw(SPDT) valve, wherein: the pole 111A is in pneumatic connection with thepump 83 and pressure sensor; one of the throws 11 is in pneumaticconnection with the diaphragm 13; and the other throw 111C is inpneumatic connection with a dead-end 113. This dead-end 113 may eitherbe a simple closed pipe, or any component(s) that does not allow theflow of air into the system 202. This could include, for example, anarrangement of one-way valves.

In this system 300, therefore, the pump 83 has the option of applyingnegative pressure directly to the pressure sensor 101. This allowsrepeated testing of the pump in order to calibrate pump systems, or todiagnose issues with the pump in what is called a dead end stop test.This is achieved by throwing the valve to connect the pump 83 to thedead end 113. The pump 83 then pulls directly against the dead end 113and the reduction of pressure within the system can be detected by thepressure sensor 101.

The pressure sensor detects when pressure is delivered and is then ableto measure the output of the pumping mechanism. The results of thepressure sensor are then sent to an external database for analysis suchas a cloud database, or are fed back to an on-board microcontroller thatis located inside the housing of the breast pump system.

Based on the pressure sensor measurements, the breast pump system isable to dynamically tune the operation of the pumping mechanism (i.e.the duty or pump cycle, duration of a pumping session, the voltageapplied to the pumping mechanism, the peak negative air pressure) inorder to ensure a consistent pressure performance across differentbreast pump systems.

In addition, the breast pump system, using the pressure sensormeasurements, is able to determine if the pump is working correctly,within tolerance levels. Material fatigue of the pump is thereforedirectly assessed by the breast pump system. Hence, if the output of thepumping mechanism degrades over time, the breast pump system can tunethe pumping mechanism operation accordingly. As an example, the breastpump system may increase the duration of a pumping session or thevoltage applied to the pumping mechanism to ensure the expectedpressures are met.

This ensures that the user experience is not altered, despite thechanging output of the pump as it degrades over time. This isparticularly relevant for piezo pumps where the output of the pump mayvary significantly.

The microcontroller can also be programmed to deliver pre-set pressureprofiles. The pressure profiles may correspond to, but not necessarily,any suction patterns that would mimic the sucking pattern of an infant.The patterns could mimic for example the sucking pattern of a breastfedinfant during a post birth period or at a later period in lactation.

The profiles can also be manually adjusted by the user using a controlinterface on the housing of the breast pump system or on an applicationrunning on a connected device.

Additionally, the user is able to manually indicate the level of comfortthat they are experiencing when they are using the system. This can bedone using a touch or voice-based interface on the housing of the breastpump system itself or on an application running on a connected device.

The system stores the user-indicated comfort levels together withassociated parameters of the pumping system. The pressure profiles maythen be fine scaled in order to provide the optimum comfort level for aparticular user.

The profiles or any of the pumping parameters may be calculated in orderto correlate with maximum milk expression rate or quantity.

The pressure profiles or any of the pumping parameters may also bedynamically adjusted depending on the real time milk expression rate orquantity of milk collected. The pressure profiles or any of the pumpingparameters may also be dynamically adjusted when the start of milklet-down has been detected.

Additionally, the system is also able to learn which parameters improvethe breast pump system efficiency. The system is able to calculate oridentify the parameters of the pumping mechanism that correlate with thequickest start of milk let-down or the highest volume of milk collectedfor a certain time period. The optimum comfort level for a particularuser may also be taken into account.

FIG. 12 shows a schematic for a system 400 for a breast pump 100 whichcan estimate the volume of milk collected in the collection container 3from data collected on the air-side part 202 of the system 400.

The pump 83 is connected to the circuit via two bleed valves 126, 128.The first bleed valve 126 is arranged to function when the pump 83applies a negative pressure. As such, this valve 126 is connected to a“bleed in” 127, for supplying atmospheric air to the system 202.

The second bleed valve 128 is arranged to function when the pump 83applies a positive pressure. As such, this valve 128 is connected to a“bleed out” 129 for bleeding air in the system 202 to the atmosphere.

Although Section C describes the preferred embodiment for measuring orinferring the volume of milk collected in the milk collection containerusing IR sensors, an alternative method for measuring or inferring thevolume of milk collected in the milk collection container using pressuresensors is described also below.

During a milking pump cycle, the pump 83 applies negative pressure onthe air side 13B of the diaphragm 13 which causes its extension towardsthe pump 83. This increases the volume of the space on the milk side 13Bof the diaphragm 13. This conveys the decrease in pressure to the breastto encourage expression of milk. A set of three non-return valves 121,123, 125 ensure that this decrease in pressure is applied only to thebreast (via the breast shield 7) and not the milk collection container3. To measure the volume of milk collected in the container 3, the pump83 is used instead to apply positive pressure to the diaphragm 13. Thediaphragm 13 is forced to extend away from the pump 83 and conveys thepressure increase to the milk side 201 of the system 400. The threenon-return valves 121, 123, 125 ensure that this increase in pressure isexclusively conveyed to the milk collection container 13.

The breast pump may further comprise: a first non-return valve betweenthe milk flow side of the diaphragm and the breast shield, configured toallow only a negative pressure to be applied to the breast shield by thepump; a second non-return valve between the milk-flow side of thediaphragm and the milk collection container configured to allow only apositive pressure to be applied to the milk collection container by thepump; and a pressure sensor in pneumatic connection with thepressure-generation side of the diaphragm.

The resulting pressure increase is monitored behind the diaphragm 13from the air-side 202 by a pressure sensor 101. Preferably, the pressuresensor 101 is a piezoelectric pressure sensor (piezo pressure sensor).The rate at which the pump 83 (at constant strength) is able to increasethe pressure in the system 400 is a function of the volume of air thatremains in the milk collection container 3. As air is many times morecompressible than liquid, the rate at which pressure increases in thesystem 400 can be expressed as an approximate function of the volume ofmilk held in the collection container 3.

Thus by increasing the pressure in this fashion, the rate of pressureincrease can be determined, from which the volume of milk held in thecontainer 3 is calculable. FIG. 13 shows repeated milking and volumemeasurement cycles as the collection container 3 is filled. To determinethe rate of pressure increase the pump 83 was run for a fixed time. Aspumping proceeds and the volume of air reduces in the system 400, thepump 83 is able to achieve a higher pressure. Each milking cycle isrepresented by a positive pressure spike 41. There is a clear upwardstrend 43 in magnitude of positive pressures achieved as the collectioncontainer 3 is filled.

A method of estimating the pressure applied by a breast pump maycomprise the steps of: selecting a pressure cycle from a pre-definedlist of pressure cycles; applying pressure with the pump to stimulatemilk expression; reading the output of the pressure sensor; andadjusting the applied pressure of the pump to match the pressure profileselected. This allows for repeatable application of force to the breast,even as the pump performance degrades.

Preferably the method further comprises the steps of: approximating theelasticity and extension of the diaphragm at the relevant pressure; andcalculating an estimated applied pressure based upon the output of thepressure sensor and the approximated elasticity and extension of thediaphragm.

Alternatively, a method of estimating the milk collected by a breastpump may comprise the steps of: generating a positive pressure with thepump; transmitting the positive pressure via the diaphragm and secondnon-return valve to only the milk collection container; measuring theincrease in pressure by the pressure sensor in pneumatic connection withthe diaphragm; estimating the volume of milk inside the milk collectioncontainer based upon the rate of increase of pressure. In this manner,the volume of milk can be estimated remotely.

In this manner, an estimate can be obtained for the volume of milk inthe container 3 based upon the measured pressures.

FIG. 13 also shows a dead end stop pump test 45 as described above. Thenegative spike shows the application of negative pressure directly tothe pressure sensor 101.

2. Breast Shield Sizing and Nipple Alignment

The correct sizing of the breast shield and the alignment of the nipplein the breast shield are key for an efficient and comfortable use of thebreast pump. However breast shape, size as well as nipple size andposition on the breast vary from one person to another and one breastfrom another. In addition, women's bodies often change during thepumping life cycle and consequently breast shield sizing may also needto be changed. Therefore, a number of breast shield sizes are available.Guide lines for correct nipple alignment are also provided.

With reference to FIG. 14, three breast shield sizes are shown (A1, B1,C1). The substantially clear breast shield gives an unobstructed view ofthe breast and allows a user to easily confirm that she has theappropriate sized shield for her breast.

In order to determine the correct breast shield size and nipplealignment, the breast shield and the diaphragm are detached from thehousing and placed on the breast with the sizing symbol facing upwards(with the diaphragm positioned below the nipple) and the nipple alignedin the centre of the fit lines (as shown in A2, B2, C2). The transparentbreast shield allows the user to observe the nipple while adjusting theposition of the breast shield in order to align the nipple correctlynear the centre of the breast shield nipple tunnel. Prior to using thepump, the nipple is aligned correctly, and the breast shield is pushedinto place ensuring the seal is correctly positioned on the breastshield. The fit lines should be directly aligned with the outside of thenipple. The correct alignment is illustrated B2.

When the nipple is correctly aligned, the user then rotates the breastshield in order for the diaphragm to be positioned on top of the nipple.The user may then quickly assemble the rest of the breast pump (i.e. thehousing and the milk container) on the breast shield via a one-clickattachment mechanism confirming correct engagement, which may beperformed one-handed. Nipple alignment may therefore be easilymaintained. Audio and/or haptic feedback may also be provided to furtherconfirm correct engagement.

3. Connected Device Application

FIGS. 15 to 20 show examples of screenshots of a connected deviceapplication that may be used in conjunction with the breast pump systemas described above. The interface shown here is an example only and thesame data may be presented via any conceivable means including animatedgraphics, device notifications, audio or text descriptions.

FIG. 15 shows a homepage of the application with different functionsprovided to the user which can be accessed either directly while pumpingor at a later time in order for example: to review pump settings or thehistory of previous pumping sessions.

FIG. 16 shows a status page with details of remaining battery life,pumping time elapsed and volume of milk inside the milk container.

FIG. 17 shows screenshots of a control page, in which a user is able tocontrol different pump parameters for a single breast pump (A) or twobreast pumps (B). The user may press on the play button to either start,pause, or resume a pumping activity. The user may also directly increaseor decrease the rate of expression using the (+) or (−) buttons. Whenonly one breast is being pumped (A), the user may also indicate if it iseither the right or left breast that is being pumped. The user may alsocontrol the pump peak pressure or alternatively may switch betweendifferent pre-programmed pressure profiles such as one mimicking thesucking pattern of a baby during expression or stimulation cycle.

FIG. 18 shows a page providing a summary of the last recorded pumpingsession.

FIG. 19 shows a page providing a history of previous pumping sessions.The user may scroll down through the page and visualize the data relatedto specific pumping sessions as a function of time.

The application is also capable of providing notifications relating topumping. FIG. 20 shows a screenshot of the application, in which a useris provided a notification when the milk collection bottle is full.Other generated notifications may include warnings about battery life,Bluetooth connection status or any other wireless communication status,status of miss-assembly, excessive movement or lack of expression.

FIG. 21 shows a further example with a screenshot of an applicationrunning on a connected device. The page shows the pumping status when auser is using a double pump mode of operation with a pump on eachbreast. The user is able to manually control each pump individually andmay start, stop or change a pumping cycle, increase or decrease eachpump peak pressure, or switch between different pre-program pressureprofiles such as one mimicking the sucking pattern of a baby during anexpression or stimulation cycle. The application also notifies the userwhen a milk collection container is nearly full as shown in FIG. 22.

FIG. 23 shows a status page with an alert notifying the user that themilk collection container of the pump on the right breast is full. Amessage is displayed that the pump session has paused and that the milkcollection container should be changed or emptied before resumingpumping.

With reference to FIG. 24, when the left and right pump are stopped orpaused, the application displays the elapsed time since the start ofeach session (right and left), the total volume of milk collected ineach bottle.

With reference to FIG. 25, a page summarizing the last session (with adouble pump mode) is displayed.

In addition to the data provided to the user, and their interactionswith the application, the app will also hold data that the user does notinteract with. For example, this may include data associated with pumpdiagnostics. In addition to all functions and sources of data discussedabove, the application may itself generate metadata associated with itsuse or inputs, notes or files uploaded by the user. All data handledwithin the mobile application can be periodically transferred to a clouddatabase for analysis. An alternative embodiment of the breast pumpsystem may include direct contact between the database and the pump, sothat pumping data may be conveyed directly, without the use of asmartphone application.

In addition to providing data to the cloud, the application may alsoprovide a platform to receive data including for example firmwareupdates.

4. Breast Pump Data Analysis

The discreet, wearable and fully integrated breast pump may offer liveexpression monitoring and intelligent feedback to the user in order toprovide recommendations for improving pump efficiency or performance,user comfort or other pumping/sensing variables, and to enable the userto understand what variables correlate to good milk flow.

Examples of variables automatically collected by the device are: time ofday, pump speed, pressure level setting, measured pressure, pressurecycle or duty cycle, voltage supplied to pumps, flow rate, volume ofmilk, tilt, temperature, events such as when let-down happens, when asession is finished. The user can also input the following variables:what side they have pump with (left or right or both), and the comfortlevel.

This is in part possible because the live milk volume measurement systemfunctions reliably (as discussed in Section B). The breast pump systemincludes a measurement sub system including IR sensors that measures orinfers milk flow into the milk container, and that enables a dataanalysis system to determine patterns of usage in order to optimallycontrol pumping parameters. The generated data may then be distributedto a connected device and/or to a cloud server for analysis in order toprovide several useful functions.

FIG. 26 illustrates an outline of a smart breast pump system networkwhich includes the breast pump system (100) in communication with aperipheral mobile device and application (270) and several cloud-baseddatabases (268, 273). The breast pump system (100) includes severalsensors (262). Sensor data refers to a broad definition including datagenerated from any sensor or any other analogue/digital reading directlyfrom the motherboard or any other component. However, within theembodiment detailed, these measurements include one or more of thefollowing, but not limited to: milk volume measurements, temperaturesensor readings, skin temperature sensing, pressure sensor readings,accelerometer data and user inputs through any physical deviceinterface.

The device also contains a number of actuators, including, but notrestricted to: piezoelectric pump(s), solenoid valve(s), IREDs and anLED display. Sensors and actuators within the device are coordinated bythe CPU (263). In addition, any interactions, and data from thesecomponents, may be stored in memory (264).

Further to these components, the device also contains a communicationchip, such as a Bluetooth chip (265) which can be used to communicatewirelessly with connected devices such as a peripheral mobile device(270). Through this connection any sensor data (267) generated in thebreast pump can be sent to the connected device. This user data, alongwith any other metadata generated from a connected device app, can beprovided to an online database which aggregates all user data (273). Inaddition, the communication chip will also allow the sending of usercontrol data/firmware updates from the connected device to the breastpump system (266).

Raw data (271) collected from the measurement sub-system includingsensors (262) may be analysed on a cloud database and the analysed datamay be stored on the cloud (272). Through inferences provided by theanalysed data, firmware updates (269) may be developed. These can beprovided for download to the pump through, for example, an onlinefirmware repository or bundled with the companion app in the connecteddevice app store (268).

In addition, it should be appreciated that despite the sophistication ofthe proposed breast pump network, the breast pump still retains completefunctionality without wireless integration into this network. Relevantdata may be stored in the device's memory (264) which may then be lateruploaded to the peripheral portion of the system when a connection isestablished, the connection could be via USB cable or wireless.

The measurement sub-system may analyse one or more of the following:

-   -   the quantity of the liquid in the container above its base;    -   the height of the liquid in the container above its base;    -   the angle the top surface of the liquid in the container makes        with respect to a baseline, such as the horizontal.

Based on whether the quantity and/or the height of the liquid in thecontainer above its base is increasing above a threshold rate ofincrease, a haptic and/or visual indicator indicates if the pump isoperating correctly to pump milk. For example, the visual indicator is arow of LEDs that changes appearance as the quantity of liquid increases.

The visual indicator may provide:

-   -   an estimation of the flow rate;    -   an estimation of the fill rate;    -   an indication of how much of the container has been filled.

As a further example, an accelerometer may infer the amount of movementor tilt angle during a pumping session. If the tilt angle excesses athreshold, the system warns or alerts the user of an imminent spillage,or provides the user with an alert to change position. Alternatively,the system may also stop pumping to prevent spillage, and once the tiltangle reduces below the threshold, pumping may resume automatically. Bysensing the movement or tide angle during a pumping session, the systemmay also derive the user's activity such as walking, standing or lying.

Many variables can affect milk expression and data analysis of thesemultiple variables can help mothers to achieve efficient pumping regimesand improve the overall user experience.

Therefore, the measurement sub-system measures or infers milk flow intothe milk container and enables a user to understand what variables (e.g.time of day, pump setting) correlates to good milk flow. The amount ofmilk expressed over one or more sessions is recorded as well asadditional metrics such as: time of day, pump setting, length of asingle pumping session, vacuum level, cycle times, comfort, liquidsconsumed by the mother. Live data or feedback is then provided to theuser to ensure the breast pump is being used properly and to support theuser in understanding the variables that would correspond to thespecific individual optimum use of the breast pump.

Furthermore, live data can be used to automatically and intelligentlyaffect specific pumping parameters in order to produce the mostefficient pumping session. For example, if the rate of expressionincreases, the milking cycle might be adjusted accordingly to achieve amore efficient, or more comfortable pumping cycle.

The measurement sub-system also enables a data analysis system todetermine patterns of usage in order to optimally control pumpingparameters. Collected metrics are transferred through wirelessconnections between the pump, a connected device or app and a clouddatabase. Additionally, the application can also connect to other appsresiding on the connected device, such as fitness app or social mediaapp or any other apps. Further metrics may also include the behaviour orspecific usage of the user associated with the connected device whileusing the pump (detection of vision and/or audio cues, internet usage,application usage, calls, text message).

Different aspects of pumping can be automatically changed based ondynamic sensor feedback within the breast pump device. The data analysissystem is able to access real-time data of pumping sessions and may beused to perform one or more of the following functions, but not limitedto:

-   -   indicate whether the milk is flowing or not flowing,    -   measure or infer the quantity and/or height of the liquid in the        container above its base,    -   give recommendations to the mother for optimal metrics for        optimal milk flow,    -   give recommendations to the mother for optimal metrics for        weaning,    -   give recommendations to the mother for optimal metrics for        increasing milk supply (e.g. power pumping),    -   give recommendations to the mother for optimal metrics if an        optimal session start time or a complete session has been        missed,    -   automatically set metrics for the pumping mechanism, such as        length of a single pumping session, vacuum level, cycle times.    -   automatically stop pumping when the milk container is full,    -   automatically adjust one or more pumping parameters to achieve        an optimum pumping session,    -   automatically adjust one or more pumping parameters to achieve a        comfortable pumping session,    -   automatically change the pumping cycle from a programmed cycle        to another different programmed cycle, such as from a        stimulation cycle to an expression cycle.

In addition, sensor feedback might be used to improve the physicalfunction of the breast pump system itself. For example, an array ofpiezoelectric pumps may be dynamically adjusted in response to theiroperating temperatures so as to optimise the total life of the componentwhist maintaining peak pressures.

Many additional embodiments may be described for these simple feedbacksystems, yet the premise remains: real-time sensor feedback is used toautomatically and dynamically adjust actuator function. Each feedbackprogram may feasibly include any number and combination of data sourcesand affect any arrangement of actuators.

The data generated can also be used to generate large datasets ofpumping parameters, user metadata and associated expression rates,therefore allowing the analysis of trends and the construction ofassociations or correlations that can be used to improve pumpingefficiency, efficacy or any function related to effective milkexpression. The analysis of large user datasets may yield useful generalassociations between pumping parameters and expression data, which maybe used to construct additional feedback systems to include on firmwareupdates.

Multiple data sources can be interpreted simultaneously and severaldifferent changes to pumping might be actuated to increase pumpingefficiency, user experience or optimize pump performance.

Collected metrics may be anonymized and exported for sharing to otherapps, community or social media platforms on the connected device, or toan external products and services, such as community or social mediaplatform. By contrasting the performance of different users in thecontext of associated metadata, users may be grouped into discrete‘Pumper profiles’ or communities, which may then be used to recommend,or action the most appropriate selection of intelligent feedback systemsto encourage efficient expression. For example, a higher peak pressuremay be recommended for women who tend to move more whilst pumping, so asto achieve more efficient expression.

Section B: IR System

This section describes the milk detecting system used in the Elvie™pump.

With reference to FIGS. 27 and 28, there is shown a device 270 for usein detecting the level of liquid inside a container 275. The device 270is formed of a housing 271 in which is located a sensing assembly 272comprising a series of optical emitters 273 (an array of three opticalemitters is used on one implementation) which are relative to, and eachlocated at a distance from, an optical receiver 274. In operation of thedevice as will be described, each optical emitter 273 is operable toemit radiation which is received by the optical receiver 274. In anembodiment of the invention, the series of optical emitters are eachlocated equidistant from the optical receiver 274.

The optical emitters 273 and the optical receiver 274 from the sensingassembly 272 are located in a portion 276 of the device 270 which facesthe container 275 when the device is connected to the container 275. Theportion 276 of the device 270 containing the optical emitters 273 andthe optical receiver 274 comprises a window 277 of material which istransparent to optical radiation. In this way, each of the opticalemitters 273 and the optical receiver 274 have a line of sight throughthe window 277 into the container 275 when the device 270 is connectedthereto.

A controller 278 comprising a CPU 279 and a memory 280 is provided inthe device 270 for controlling the operation of the sensing assembly272. An accelerometer 281 is also provided in the housing 271, which isoperatively connected to the controller 278. Operation of the device 270when connected to the container 275 will now be described.

In a principal mode of operation, to determine the level L of liquidinside the container 275, the controller 278 instructs the opticalemitters 273 to each emit radiation towards the surface of the liquidinside the container 275 at a given intensity. The optical receiver 274receives the reflected radiation from each optical emitter 273 via thesurface of the liquid and each of these intensities is recorded by thecontroller.

For each operation of the sensing assembly 272, the controller 278records the intensities of radiation emitted by each of the opticalemitters 273 as intensities IE1; IE2 . . . IEn (where n is the totalnumber of optical emitters), and records the intensities of radiationreceived by the optical receiver 274 from each of the optical emitters273 as received intensities IR1; IR2 . . . IRn.

By comparing the emitted radiation intensities IE1; IE2 . . . IEn withthe received radiation intensities IR1; IR2 . . . IRn, the controller278 calculates a series of intensity ratios IE1:IR1; IE2:IR2 . . .IEn:IRn, which are then used to determine the level of the liquid insidethe container. At the most basic level, if the intensity ratio ofIE1:IR1 is the same as IE2:IR2, given the optical emitters 273 areequidistant from the optical receiver 274, this indicates that the levelof the liquid inside the container is parallel to the top of the bottle,as shown in FIG. 27. In contrast, if these two intensity ratios aredifferent, this indicates that the liquid level is at a different angle,such as that shown in FIG. 28.

To accurately determine the level and the quantity of liquid inside thecontainer 275, the controller 278 processes the recorded intensityratios using a database located in the memory 280. The database containsan individual record for each container which is operable to connectwith the device 270. Each record from the database contains a look-uptable of information, which contains expected intensity ratios (IE1:IR1and IE2:IR2) for the container 275 when filled at differentorientations, and with different quantities of liquid.

By comparing the information from the look-up table with the recordedintensity ratios, the controller 278 calculates the level and quantityof liquid inside the container 275 and stores this information in thememory 280.

In situations where a container 275 to the device 270 contains no storedrecord in the database, the sensing assembly 272 can be used in acalibration mode to create a new record. In the calibration mode, thesensing assembly 272 is operated as the container is filled from empty,and as it is positioned at different orientations. At each point duringthe calibration mode, the controller 278 calculates the recordedintensity ratios (IE1:IR1 and IE2:IR2) and stores them in the recordrelating to the container 275. For each set of recorded intensityratios, the user includes information in the record relating to theorientation and fill level of liquid inside of the container 275.

To improve the accuracy of the results obtained by the device 270 duringits use, the controller 278 when recording each intensity ratio alsorecords a parameter from the accelerometer 281 relating to theacceleration experienced by the device 270. For each recordedacceleration parameter, the controller 278 determines whether theparameter 278 exceeds a predetermined threshold acceleration parameterstored in the memory 280. The predetermined threshold is indicative ofan excessive acceleration, which causes sloshing of liquid inside thecontainer 275 connected to the device 270. In the event of a recordedacceleration parameter exceeding the predetermined thresholdacceleration parameter, the controller 278 flags the recorded intensityratios associated with the recorded acceleration parameter as beingunreliable (due to sloshing).

Even without the use of the accelerometer 281, the controller 278 isnonetheless operable to determine whether a set of recorded intensityratios occur during a period of excess acceleration. In this regard, foreach set of intensity ratios recorded at a given time, the controller278 checks whether any of these intensity ratios is of a predeterminedorder of magnitude different than the remaining recorded intensityratios from the set. In the event that the controller 278 determinesthat this is the case, this indicates that the liquid inside thecontainer has ‘sloshed’ as a result of the excess acceleration, as shownin FIG. 29. In this event, the controller 278 flags the set of recordedintensity ratios as being unreliable.

It will be appreciated that instead of recording the relativeintensities of radiation emitted by the optical emitters 273 with theradiation received by the optical emitter 274, the controller 278 couldinstead record the time taken for radiation emitted by each of theoptical emitters 273 to be received by the optical receiver 274. In thisarrangement, the look up table would instead contain time periods asopposed to intensity ratios.

In terms of the applications for the device 270, it will be appreciatedthat the device can be used in a wide variety of applications. Onepossible application is the use of the device 270 to determine the levelof liquid located within a container 275, such as a baby bottle, used aspart of a breast pump assembly. In this arrangement, the device 270 isassociated with a breast pump 301 which assists with the expression ofmilk from a breast. The breast pump may be located in the housing 271 ofthe device 270 as shown in FIG. 30, or it may be realizably connected tothe housing 271.

Either way, the device 270 would be connectable to the container 275such that milk expressed by the breast pump can pass from the pump via achannel 302 into the container 275.

The breast pump may be any type of breast pump system including anyshapes of milk container or bottle and may comprise a pump module forpumping milk from a breast. The pump module being contained within thehousing may comprise: a coupling, a container attachable to the housingvia the coupling to receive milk from the pump, a sensing assemblywithin the housing and comprising at least one optical emitter operableto emit optical radiation towards the surface of the body of milk heldin the container when the housing is connected to the container, anoptical receiver for receiving the reflected radiation from the surfaceof the milk, and a controller electrically connected to the sensingassembly for receiving signals from the optical receiver and calculatingthe level of the milk inside the container based on the reflectedradiation received by the optical receiver.

By determining the level of milk inside the container based on reflectedradiation from the surface of the milk in the container, there is noneed to monitor the individual droplets of milk entering the container,such that the sensing assembly can avoid errors associated withmeasuring these droplets. For example, because we take multiplereflection-based measurements once the container is filled, we cangenerate an average measurement that that is more accurate than a singlemeasurement. But with systems that rely in counting individual droplets,that is not possible—further, systemic errors (e.g. not countingdroplets below a certain size) will accumulate over time and render theoverall results unreliable. Furthermore, by not needing to measure thesedroplets, the sensing assembly from the breast pump need not always beon during the pumping process, which saves power.

When at least two optical emitters are used, the sensing assembly fromthe breast pump may determine the level of milk inside the containermore accurately and irrespective of the orientation of the liquid levelinside the container.

Each optical emitter may be equidistant from the optical receiver inorder for the controller to easily calculate the level of the milkinside the container based on the reflected radiation originating fromeach optical emitter. The signals from the optical receiver preferablycomprise information relating to the intensity of the radiation receivedby the optical receiver.

Each optical emitter may be operable to emit radiation at a differentwavelength, or at a different time, than the other optical emitters. Inthis way, the controller can more easily process the signals from theoptical receiver, and more easily distinguish between the radiationemitted by each of the optical emitters.

The optical emitter may emit radiation in the visible range ofwavelengths. Alternatively, it may be UV or IR light. The emittedwavelength may be for example between 10 nm and 1 mm.

The sensing assembly may also comprise at least one accelerometerelectrically connected to the controller. The controller may beconfigured to record an accelerometer parameter from the accelerometerand determine whether the accelerometer parameter exceeds apredetermined threshold. The predetermined threshold may be indicativeof an excessive acceleration, which might cause sloshing of milk insideany container connected to the breast pump.

Another application for the device 270 is as a collar for detecting thelevel/quantity of liquid in a container 275, such as a baby bottle, viaits lid 310. An example of the device 270 being used as such a collar isshown in FIG. 31. In this arrangement, the device 270 is located betweenthe container 275 and the lid 310, and comprises a first end 311 havinga first coupling 312 for attaching the collar to the lid 310. The devicecomprises a second end 313 having a second coupling 314 for attachingthe device 270 to the container 275. The second coupling may be a screwthread, shown in FIG. 31, on the inside surface of the container 275. Inthis way, the distinctive bottom inside surface can be used by thesensing assembly 272 to more easily calibrate itself to the container275 on which the distinctive bottom inside surface is located. Thedistinctive bottom may also be used to help identify which container 275the device is connected to, and thus which record should be used fromthe database when the device 270 is used.

To further improve the accuracy of the sensing assembly 272, thecontroller 278 may also be configured to use the recorded informationfrom the accelerometer 281, in situations where the record accelerationis below the predetermined threshold acceleration parameter, tocalculate a more accurate liquid level and/or quantity of liquid locatedinside the container which is compensated for acceleration.

In one particular arrangement, the controller 278 may poll theaccelerometer 281 prior to each operation of the sensing assembly 272 toverify that the device 270 is not currently undergoing excessiveacceleration. In the event of the controller 278 determining excessiveacceleration in the device 270, the controller 278 would continuallyre-poll the accelerometer, and not operate the sensing assembly 272,until the parameter from the accelerometer is determined as being belowthe predetermined threshold acceleration parameter stored in the memory280.

It will also be appreciated that for each container record stored in thedatabase, the container record may comprise a plurality of look uptables, wherein each look up table is associated with a particularliquid used in the container, and wherein each look up table containsits own set of intensity ratios. In this way, the device 270 can moreaccurately determine the level/quantity of different liquids used in aparticular container 275.

As described herein, the sensing assembly 272 has been described ashaving a plurality of optical emitters 273. It will be appreciatedhowever that the sensing assembly could operate using a single opticalemitter 273 and plurality of optical receivers 274. In this arrangement,each record from the database would contain a plurality of ratiosrelating to the emitted radiation from the optical emitter 273 asreceived by each of the optical receivers 274. In use of the device 270,the controller 278 would then similarly record the emitted radiationfrom the optical emitter 273 as received by each of the opticalreceivers 274. In an alternate arrangement, there may be provided aplurality of optical emitters 273 and a plurality of optical receivers274, wherein each optical emitter 273 is associated with a respectiveoptical receiver 274. In its simplest arrangement, the sensing assembly272 may comprise a single optical emitter 273 and a single opticalreceiver 274.

In certain configurations, the optical emitters 273 may together emitradiation having the same wavelength. In other configurations, theoptical emitters 273 may each emit radiation having a differentwavelength. In this latter configuration, the optical receiver 274 wouldthen be able to determine which optical emitter 273 is associated withany given received radiation, based on the wavelength of the receivedradiation.

The optical emitters 273 may also each emit radiation at differenttimes, such to allow the controller 278 to more easily process thesignals from the optical receiver 274, and more easily distinguishbetween the radiation emitted by each of the optical emitters 273.

In relation to the electrical connection between the controller 278 andthe sensing assembly 272, it will be appreciated this electricalconnection may be either a wired/wireless connection as required.

Although not shown in the Figures, the device 270 herein described ispreferably powered by a battery or some other power source located inthe device 270. In other embodiments, the device 270 may be poweredusing mains electricity.

In one configuration, it is also envisaged that rather than thecontroller 278 comparing the information from the look-up table with therecorded intensity ratios to calculate the level and quantity of liquidinside the container 275, the controller 278 could instead process therecorded intensity ratios through a liquid-level equation stored in thememory 280. In this configuration, the liquid-level equation could be ageneralised equation covering a family of different containers, or couldbe an equation specific to a container having a given shape and/or typeof liquid inside.

It will also be appreciated that in some applications of the device 270,the device could be used to detect the level of a solid, as opposed to aliquid, in a container. As used herein, the terms ‘optical emitter’ and‘optical receiver’ are intended to cover sensors which can emitradiation in or close to the optical wavelength. Any type of radiationat or close to the optical wavelength is suitable provided that it doesnot have any harmful effects. The exact wavelength is not important inthe context of the invention. Such sensors thus include those which canemit visible radiation (such as radiation having wavelengths in theregion of 400 nm-700 nm), and/or those which can emit IR radiation (suchas radiation having wavelengths in the region of 700 nm-1 mm and/orthose which can emit UV radiation (such as radiation having wavelengthsin the region of 10 nm to 400 nm).

Existing prior art for such a sensor module is the apparatus disclosedin RU2441367. In this apparatus, the container is an industrially sizedmilk tank, which only includes a single laser mounted at the top of thetank. Whilst this apparatus is suited for large-sized containers, whichdo not move in use, the apparatus is less-suited for applications wherethe container moves in use, or where the liquid level inside thecontainer is non perpendicular to the laser beam shone into thecontainer. In contrast, the sensor module described above can be used ina variety of different applications, is conveniently located within ahousing, and which by virtue of it having at least two optical emitters,can determine the level of liquid even inside containers of irregularshapes, and which can determine the level of liquid inside a containerirrespective of the orientation of the liquid level inside thecontainer.

Further to the embodiments of the fluid measurement system in differentcontexts, it can be appreciated that different functions entirely may bepossible using the same component structure. For example, it is knownthat certain molecules within breast milk absorb specific wavelengths oflight at characteristic propensities. Whilst the proposed system usesmultiplexed IREDs at the same wavelengths to perform proximitymeasurements, the same array of IREDs may instead be used to emitseveral different wavelengths of light and determine their absorptionupon reflection. If appropriately calibrated, the system may be able toreport on the presence or concentration of specific compounds in theexpressed milk, such as fat, lactose or protein content.

In addition to this embodiment, it is feasible that the system might beapplied to monitor the change in volume of any other container ofliquid, given there is sufficient reflection of IR off its surface.These embodiments might include for example: liquid vessel measurementsuch as for protein shakes, cement or paint, or volume measurementswithin a sealed beer keg.

Section C: Bra Clip

This section describes a bra clip that forms an accessory to the Elvie™pump.

It relates to a system allowing a user to quickly and simply adjust thecup size of a maternity bra to allow discrete and comfortable insertionand use of an integrated wearable breast pump. As such, the user doesnot need a specialised adjustable bra; instead the present system workswith all conventional maternity bras. The user also does not have topurchase any larger bras to wear while pumping.

As shown in FIG. 32, a typical maternity bra 320 comprises a supportstructure made up of shoulder straps 321 which support the bra 320 onthe wearer's shoulders, and a bra band 322 for extending around a user'sribcage, comprising two wings 323 and a central panel or bridge 324. Thestraps 321 are typically provided with adjustment mechanisms 325 forvarying the length of the straps 321 to fit the bra 320 to the wearer.At the outermost end of each wing, an attachment region 326 is provided.Typically, hooks 327 and loops 328 are provided for securing the bra 320at the user's back. However, any other suitable attachment mechanism maybe used. Alternatively, the attachment region 326 may be provided at thefront of the bra 320 in the bridge region 324, with a continuous wing323 extending continuously around the wearer's back. Typically, a numberof sets of loops 328 are provided to allow for variation in thetightness of the bra 320 on the wearer. While shown as having aseparation in FIG. 32, the wings 323 and bridge 324 may form a singlecontinuous piece in certain designs. Likewise, while shown with adistinct separation in FIG. 32, the shoulder straps 321 and the wings323 may likewise form a single continuous piece.

The maternity bra 320 is further provided with two breast-supportingcups 329 attached to the support structure. The cups 329 define a cupsize, which defines the difference in protrusion of the cups 329 fromthe band 322. The European standard EN 13402 for Cup Sizing defines cupsizes based upon the bust girth and the underbust girth of the wearerand ranges from AA to Z, with each letter increment denoting a 2 cmdifference between the protrusion of the cups 329 from the band 322.Some manufacturers do vary from these conventions in denomination, andsome maternity bras are measured in sizes of S, M, L, XL, etc.

The cups 329 may be stitched to the bra band 321. At least one of thecups 329, is in detachable attachment with the corresponding strap 321.In particular, this is achieved at attachment point 330 where a hook 331attached to the bra strap 321 engages with a clasp 331 attached to thecup 329. The hook 331 and the bra strap adjuster 325 are set such thatin the closed position, the cup size of the bra 320 fits the wearer'sbreasts.

In FIG. 32, the left cup 329 is shown attached to its attachment point330, which the right cup 329 is unattached. In this manner, the weareris able to detach the cup 329 to expose their breast for feeding or forbreast pumping. Once this is completed, the cup 329 is reattached andthe maternity bra 320 continues to function as a normal bra.

While in the depicted embodiments, a hook 331 is shown on the bra strap321 and a clasp 332 is shown on the cup 329, it is appreciated that theprovision of these may be reversed, or that alternative attachmentmechanisms may be used.

A maternity bra therefore may comprise a support structure comprisingshoulder straps and a bra band and a first and a second cup eachattached to the support structure to provide a first cup size, at leastone cup being at least partially detachable from the support structureat an attachment point.

In other embodiments, the detachable attachment point 330 may beprovided at a different location, such as at the attachment between thebra band 322 and the cup 329. The mechanism for such an attachment pointis the same as described above.

A clip has been designed such that it is configured to be attached tothe support structure at a position away from the attachment point. Thisresults in the original attachment point being usable, with the clipproviding an alternative attachment point to give, in effect, anadjusted cup size.

Alternatively, the clip may also be attachable to the support structureat a plurality of non-discrete positions. This ensures essentiallyinfinite adjustment of the clip position such that the perfect positionfor the user can be found.

The clip can also extend between an unextended and an extended state,and can attach to the support structure at the attachment point; thefirst cup size is providable when the at least partially detachable cupis attached to the clip when the clip is an unextended state; the secondcup size is providable when the at least partially detachable cup isattached to the clip when the clip is in an extended state. Anextendable clip like this allows quick switching between the two statesin use.

FIG. 33 depict a clip 335 according to the present invention, along witha clasp 332 shown in isolation from the bra cup 329 it is normallyattached to. The clip comprises a first engagement mechanism and atleast one second engagement mechanism(s). The clip is attachable in areleasable manner to the support structure at a first position via thefirst engagement mechanism and attachable in a releasable manner to oneof the partially detachable cups via the second engagement mechanism toprovide a second cup size different to the first cup size. The clip 335is provided with a material pathway 336 which receives a portion of thebra strap 321. In the particular embodiment of these Figures, the clip335 is substantially U-shaped, with a narrowing profile towards its openend. However, it is appreciated that any other suitable shape with amaterial pathway may be used, such as an S-shape or E-shape. The clip335 is designed to be attached to the bra strap 321 in a releasablemanner, with the slot 336 acting as a support engaging mechanism. Thereleasable manner means that the clip 335 may be simply removed from thebra 320 without causing any damage to the functioning of the bra 320. Toenhance the ease of attachment, the clip 335 may be provided withoutwardly extending wings 204 which help direct the bra strap 321 intothe clip 335. The clip 335 is further provided with a hook 220 acting asa cup engaging mechanism which can engage with the clasp 332.

FIG. 33 (c) shows the clip 335 being attached to a bra strap 321 inorder to provide a second attachment point 337 for the clasp 332 toattach to, and hence to provide a second cup size for the bra 320. Inthis particular embodiment, the clip 335 is attached in a portion ofstrap 321A below the original attachment point 330 and hence the secondattachment point 337 is likewise below the original attachment point.This results in a second cup size larger than the first cup size. Inpreferred embodiments, as shown in these Figures, the clip 335 engageswith the support structure in a direction transverse to the direction inwhich it engages with the cup.

FIGS. 33 (d) and (e) show how a wearer is able to move between the firstand second cup sizes. In 33(d), the cup 329 is attached at the firstattachment point 330 to provide a first cup size. The wearer thendisengages the clasp 332 from the hook 331 at the hook 338 at the secondengagement point 239. In this manner, the wearer is easily able totransition between the two cup sizes.

FIGS. 34 and 35 show an alternative design for a clip 340. This clip 340is substantially “E-shaped”, with a back portion 341 and first, secondand 5 third prongs 342A, 342B, 342C extending transverse from this backportion 341. The three prongs 342A, 342B, 342C are spaced apart alongthe length of the back portion 341. The first and third prongs 342A,342C are provided with attachment clips 343A, 343B.

These attachment clips 343A, 343B can engage with the clasp 332 of a brato provide the second cup size. Depending upon the orientation of theclip 300, one or the other of the attachment clips 343A, 343B will beused to attach the clasp 332 of the bra. By providing these clips 343A,343B on both of the first and the third prongs 342A, 342C the clip iseasily reversible so it can be used on either side of the bra.Preferably the clip 340 is also symmetrical, to aid the reversibility ofthe clip 340.

FIG. 35 shows the clip 340 attached to a bra. As can be seen, the firstand third prongs 342A, 342C extend on the front side of the bra strap,with the second prong 342B extending on the rear side of the bra strap.In this manner, the clip 340 is attached to the strap. In preferableembodiments, a grip-enhancing member 344 such as a number of projectionsand/or roughened patches can be provided on the second prong 342B inorder to strengthen this grip.

In alternative embodiments, the attachment clip could be provided on thesecond, centermost prong 342B. In such an arrangement, the centermostprong 342B would be on the outside of the bra, with the first and thirdprongs 342A, 342C on the inside.

The provision of the attachable clip allows maternity bras already ownedby the wearer to be quickly transformed into bras with quick switchabledouble cup size options.

This allows the use of integrated wearable breast pumps which increasethe user's required cup size. This allows more design freedom for thebreast pump in terms of size and shape, while still allowing the user todiscretely pump with the pump held within their bra. By allowingconversion of the user's existing maternity bras, they are not forced topurchase specially designed bras to wear with the pump. The bra is hencenormally at the first engagement point 330 when the breast pump deviceis not being used. As shown in FIG. 33, the clasp 332 is then engaged bythe user to discretely switch between the two configurations, and theuser then inserts the pump without any complex adjustment or removal ofclothing.

Preferably, the clip will be relatively unobtrusive in size and shapeand hence can be left in place when the bra is first put on and usedwhen necessary. To this end, the clip is preferably machine washablewithout significant damage or degradation.

In some embodiments, the clip may be switchable between positions forengaging with each cup so that a single clip may be used on either sideof the bra. To achieve this, the clip is preferably reversible. This mayprovide the user with a visual indication of which breast has producedmilk most recently so switching can take place.

In a preferred embodiment, the first engagement mechanism engages withthe support structure in a first direction and the second engagementmechanism engages with the cup in a second direction transverse to thefirst direction. This increases ease of attachment as with thisstructure the sideways engagement of the clip to the support structureensures that the second attachment mechanism is correctly orientated forthe cup.

The second engagement mechanism may be one or more of a hook or a snapor a clip. This ensures easy interfacing with the traditional hook andclasp systems already provided on maternity bras.

Preferably the clip further comprises two distinct second engagementmechanisms which can be used interchangeably dependent upon theorientation of the clip. This makes the clip easier to use as it can bequickly switched between each bra strap, and the user does not have toworry which way up to put the clip on.

Preferably, the clip comprises a material pathway with an opening forreceiving a portion of the support structure as the first engagementmechanism for securing the clip to the bra. This ensures a quick andsimple method for attaching the clip to the bra. In particular, the clipmay substantially U-shaped, and the material pathway is between the armsof the U.

Preferably, the clip comprises three prongs extending from a centralsupport, the three prongs arranged as a central prong and two outerprongs so as to receive the support structure on one side of the centralprong and on the opposite side of each respective outer prong, at leastone prong being provided with the second engagement mechanism. Thisensures a strong attachment to the bra and a simple design.

Preferably, both outer prongs are each provided with a respective secondengagement mechanism. This ensures that the clip is reversible foreasier attachment to the bra.

A method of adjusting the cup size of a maternity bra is providedaccording to the present invention, comprising: providing a maternitybra comprising: a support structure comprising shoulder straps and a braband; and a first and second cup each attached to the support structureto provide a first cup size, the at least one cup being detachable fromthe support structure at an attachment point, providing a clipcomprising first and section engagement mechanisms, attaching the firstengagement mechanism of the clip in a releasable manner to a firstposition of the support structure of the maternity bra, attaching one ofthe detachable cup to the second engagement mechanism of the clip in areleasable manner to provide a second cup size different to the firstcup size.

This clip and method allow a user to quickly and simply adjust the cupsize of a maternity bra to allow discrete and comfortable insertion anduse of an integrated wearable breast pump.

Preferably, the method further comprises the step of inserting a breastpump into the detachable cup. The adjustment of the size of the braallows the bra to support the breast pump against the user's breast forcomfort and ease.

Preferably, the method further comprises the steps of: detaching thefirst engagement mechanism of the clip from the first position supportstructure of the maternity bra; attaching the first engagement mechanismof the clip in a releasable manner to a second position of the supportstructure of the maternity bra; and attaching the other of thedetachable cups to the second engagement mechanism of the clip in areleasable manner to provide a second cup size different to the firstcup size. This allows the user to use a single clip on either of thecups.

An alternative embodiment may be provided, with an extendable clip 360as shown in FIG. 36. In such an embodiment the clip is attached to thehook 331 on the strap 321 in a releasable manner, with the clasp 332attached to an expandable portion of the clip. The clip is then able toexpand between an unexpanded state where the clasp 332 is held insubstantially the same position as the first attachment point 330 toprovide the first cup size, and an expanded state, where the clasp 332is held in a second position away from the first attachment point 330 toprovide the second cup size.

For example, an elongate clip with first and second opposite ends may beprovided. A first attachment point for attaching to the hook 331 isprovided at the first end, and a second attachment point for attachingto the clasp 332 is provided at the second end. The elongate clip ishinged between the two ends, such that the clip can be folded between anelongate configuration to a closed configuration where the second endtouches the first end. A clasp can be provided on the clip to hold thesecond end in this closed configuration. Thus, in the closed positionthe clasp 332 is held in substantially the same location as the firstattachment point 330 to provide the first cup size, and in the openposition the clasp is held away from the first attachment point 330 toprovide the second cup size.

Other extendable clip embodiments are also possible, for example slidingclips or elastic clips.

Additional embodiments of a maternity bra adjuster are provided in FIGS.37 and 38. The alternative proposed solution is a small adapter device,which comprises a first portion 370 including a clasp 373 and a secondportion 372 including a hook 374, in which the first and second portionsare separated by a small distance 371 in order to provide two differentadjustable sizes. The first portion includes a clasp 373 that isdesigned to attach to the hook on the bra strap 321. It may also includea top hook 375 positioned underneath the clasp, and a clip 376 on therear side. The second portion includes a bottom hook 372.

The clasp 332 that is present on the cup 329 of the maternity bra, maythen either engage with the top hook (321) to provide a first cup size,and engage with the bottom hook (332) to provide a second cup size thatis different from the first cup size, as illustrated in FIG. 39. Theuser may then discretely switch between a non pumping position, providedby the first cup size, and a second pumping position without any complexadjustment or removal of clothing needed, while using a wearable breastpump system (100).

The first portion and second portion may be made of plastic and may beseparated by a stretchy material such as elastic or elastomericmaterial. The first portion may also include a clip on the rear side,the purpose of which is to allow the user to leave the clip attached tothe bra for an extended time period.

Section D: Use of Piezo Pump in Wearables

As described in Section A, the breast pump system includes a piezo airpump, resulting in a fully wearable system that delivers a quiet,comfortable and discreet operation in normal use. This section givesfurther information on the piezo air pump.

In comparison with other pumps of comparable strength, piezo pumps aresmaller, lighter and quieter.

Each individual Piezo pump weighs approximately 6 gm and may, withmaterial and design improvements, weigh less than 6 gm.

In operation, the Elvie breast pump system makes less then 30 dB noiseat maximum power and less than 25 dB at normal power, against a 20 dBambient noise; tests indicate that it makes approximately 24 dB noise atmaximum power and 22 dB at normal power, against a 20 dB ambient noise.

Piezo pumps also have lower current draw, allowing for increased batterylife. A piezo pump is therefore ideally suited for wearable devices withits low noise, high strength and compact size. Further, as shown in thebreast pump system of FIGS. 7 and 8, more than one piezo pump may beused.

Whilst a breast pump system is largely described in previous sections,the use of piezo mounted either in series or in parallel can also beimplemented in any medical wearable devices or any wearable device. Thepiezo pump may pump air as well as any liquid.

With reference to FIG. 40, a diagram illustrating a configuration of twopiezo pumps mounted in series is shown.

With reference to FIG. 41, a diagram illustrating a configuration of twopiezo pumps mounted in parallel is shown.

With reference to FIG. 42, the air pressure generated as a function oftime by two piezo pumps mounted in series and two piezo pumps mounted inparallel are compared. In this example, the parallel configurationproduces higher flow rate and achieves −100 mmHg negative air pressurefaster than the series configuration. In comparison, the seriesconfiguration produces lower flow rate and takes slightly longer toreach 100 mmHg. However, the parallel configuration cannot achieve ashigh as a vacuum as the series configuration and plateaus at −140 mmHg.In comparison, the series configuration is able to generate about −240mmHg.

A dual configuration is also implemented in which more than one piezopump is configured such that they can easily switch between a parallelmode and a series mode. This dual configuration would suit wearabledevices that would need to achieve either lower or higher pressurefaster.

FIG. 43 shows a plot of the air pressure generated as a function of timeby two piezo pumps mounted in a dual configuration. In this dualconfiguration, the piezo pumps first start with a parallel mode in orderto benefit from faster flow rate, and then switch to a series mode (asindicated by the switch-over point) when stronger vacuums are required,enabling to save up to 500 ms on cycle time with elastic loads.

Additionally, a piezo pump may be used in combination with a heat sinkin order to efficiently manage the heat produced by the wearable pump.This configuration may be used to ensure that the wearable device can beworn comfortably. The heat sink or heat sinks are configured to ensurethat the maximum temperature of any parts of the breast pump system thatmight come into contact with the skin (especially prolonged contact forgreater than 1 minute) are no more than 48° C. and preferably no morethan 43° C.

The heat sink may store the heat produced by a piezo pump in order tohelp diverting the heat produced to another location. This not onlyensures that the wearable system can be worn comfortably, but alsoincreases the lifetime of a piezo pump.

FIG. 44 shows a picture of a wearable breast pump housing includingmultiple piezo pumps (440). The breast pump system is wearable and thehousing is shaped at least in part to fit inside a bra. By applying avoltage to the piezo pumps, the pressure provided by the pumps increase.The generation of higher pressure by the piezo pumps also means higherheat produced that needs to be managed. Each piezo pump is thereforeconnected to a heat sink (441), such as a thin sheet of copper. The heatsink has a long thermal path length that diverts the heat away from thepiezo pump.

The use of a heat sink in combination with a piezo pump is particularlyrelevant when the wearable device is worn directly or near the body, andwhere the management of heat induced by the piezo pump is crucial.

A wearable device including a piezo pump may therefore include a thermalcut out, and may allow for excess heat to be diverted to a specificlocation. The heat sink may be connected to an air exhaust so that airwarmed by the piezo pumps vents to the atmosphere. For example, thewearable system is a breast pump system and the heat sink stores heat,which can then be diverted to warm the breast shield of the breast pumpsystem.

Use cases application include but are not limited to:

-   -   Wound therapy;    -   High degree burns;    -   Sleep apnoea;    -   Deep vein thrombosis;    -   Sports injury.

APPENDIX: SUMMARY OF KEY FEATURES

In this section, we summarise the various features implemented in theElvie™ pump system. We organize these features into six broadcategories:

A. Elvie Breast Pump: General Usability Feature Cluster

B. Elvie Piezo Air Pump Feature Cluster

C. Elvie Milk Container Feature Cluster

D. Elvie IR System Feature Cluster

E. Elvie Bra Clip Feature Cluster

F. Other Features, outside the breast pump context

Drilling down, we now list the features for each category:

A. Elvie Breast Pump: General Usability Feature Cluster

-   Feature 1 Elvie is wearable and includes only two parts that are    removable from the pump main housing in normal use.-   Feature 2 Elvie is wearable and includes a clear breast shield    giving an unobstructed view of the breast for easy nipple alignment.-   Feature 3 Elvie is wearable and includes a clear breast shield with    nipple guides for easy breast shield sizing.-   Feature 4 Elvie is wearable and includes a breast shield that    audibly attaches to the housing.-   Feature 5 Elvie is wearable and includes a breast shield that    attaches to the housing with a single push.-   Feature 6 Elvie is wearable and not top heavy, to ensure comfort and    reliable suction against the breast.-   Feature 7 Elvie is wearable and has a Night Mode for convenience.-   Feature 8 Elvie is wearable and includes a haptic or visual    indicator showing when milk is flowing or not flowing well.-   Feature 9 Elvie is wearable and collects data to enable the mother    to understand what variables (e.g. time of day, pump speed etc.)    correlate to good milk-flow.-   Feature 10 Elvie is wearable and collects data that can be exported    to social media.-   Feature 11 Elvie is wearable and has a smart bottle that stores the    time and/or date of pumping to ensure the milk is used when fresh.-   Feature 12 A smart bottle that stores the time and/or date of    pumping to ensure the milk is used when fresh.-   Feature 13 Elvie is wearable and includes a sensor to infer the    amount of movement or tilt angle during normal use.-   Feature 14 Elvie includes a control to toggle between expressing    milk from the left breast and the right breast.-   Feature 15 Elvie includes a pressure sensor.-   Feature 16 Elvie includes a microcontroller to enable fine tuning    between pre-set pressure profiles.-   Feature 17 Elvie enables a user to set the comfort level they are    experiencing.-   Feature 18 Elvie includes a microcontroller to dynamically and    automatically alter pump operational parameters.-   Feature 19 Elvie automatically learns the optimal conditions for    let-down.

B. Elvie Piezo Air Pump Feature Cluster

-   Feature 20 Elvie is wearable and has a piezo air-pump for quiet    operation.-   Feature 21 Elvie has a piezo air-pump and self-sealing diaphragm-   Feature 22 Elvie uses more than one piezo air pump in series.-   Feature 23 Elvie is wearable and has a piezo air-pump, a breast    shield and a diaphragm that fits directly onto the breast shield.-   Feature 24 Elvie is wearable and has a piezo air-pump for quiet    operation and a re-useable, rigid milk container for convenience.-   Feature 25 Elvie has a piezo-pump for quiet operation and is a    connected device.-   Feature 26 Elvie uses a piezo in combination with a heat sink that    manages the heat produced by the pump.-   Feature 27 Elvie is wearable and gently massages a mother's breast    using small bladders inflated by air from its negative pressure    air-pump.-   Feature 28 Elvie is wearable and gently warms a mother's breast    using small chambers inflated by warm air from its negative pressure    air-pump.

C. Elvie Milk Container Feature Cluster

-   Feature 29 Elvie is wearable and includes a re-useable, rigid milk    container that forms the lower part of the pump, to fit inside a bra    comfortably.-   Feature 30 Elvie is wearable and includes a milk container that    latches to the housing with a simple push to latch action.-   Feature 31 Elvie is wearable and includes a removable milk container    with an integral milk pouring spout for convenience.-   Feature 32 Elvie is wearable and includes a removable milk container    below the milk flow path defined by a breast shield for fast and    reliable milk collection.-   Feature 33 Elvie is wearable and includes a breast shield and    removable milk container of optically clear, dishwasher safe plastic    for ease of use and cleaning.-   Feature 34 Elvie is wearable and includes various components that    self-seal under negative air pressure, for convenience of assembly    and disassembly.-   Feature 35 Elvie is wearable and includes a spout at the front edge    of the milk container for easy pouring.-   Feature 36 Elvie is wearable and includes a milk container that is    shaped with broad shoulders and that can be adapted as a drinking    bottle that baby can easily hold.

D. Elvie IR System Feature Cluster

-   Feature 37 Elvie is wearable and includes a light-based system that    measures the quantity of milk in the container for fast and reliable    feedback.-   Feature 38 The separate IR puck for liquid quantity measurement.-   Feature 39 The separate IR puck combined with liquid tilt angle    measurement.

E. Bra Clip Feature

-   Feature 40 Bra Adjuster.

F. Other Features that can sit outside the breast pump context

-   Feature 41 Wearable device using more than one piezo pump connected    in series or in parallel.-   Feature 42 Wearable medical device using a piezo pump and a heat    sink attached together.

We define these features in terms of the device; methods or processsteps which correspond to these features or implement the functionalrequirements of a feature are also covered.

We'll now explore each feature 1-42 in depth. Note that each feature canbe combined with any other feature; any sub-features described as‘optional’ can be combined with any other feature or sub-feature.

A. Elvie Breast Pump: General Usability Feature Cluster

Feature 1 Elvie is Wearable and Includes Only Two Parts that areRemovable from the Pump Main Housing in Normal Use

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) a breast shield;

(c) a rigid or non-collapsible milk container;

and in which the breast pump system includes only two parts that aredirectly removable from the housing in normal use or normaldis-assembly: the breast shield and the rigid, non-collapsible milkcontainer.

Optional:

-   -   The only parts of the system that come into contact with milk in        normal use are the breast shield and the milk container.    -   Milk only flows through the breast shield and then directly into        the milk container.    -   The breast shield and milk container are each pressed or pushed        into engagement with the housing.    -   The breast shield and milk container are each pressed or pushed        into a latched engagement with the housing.    -   The two removable parts are each insertable into and removable        from the housing using an action confirmed with an audible        sound, such as a click.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast and nipple tunnel shaped to        receive a nipple.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around a        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Breast shield slides into the housing using guide members.    -   housing is configured to slide onto the breast shield, when the        breast shield has been placed onto a breast, using guide        members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers, such as ball bearings, in the housing locate        into small indents in the breast shield.    -   Breast shield latches into position against the housing using        magnets.    -   Breast shield includes or operates with a flexible diaphragm        that (a) flexes when negative air pressure is applied to it by        an air pump system in the housing, and (b) transfers that        negative air-pressure to pull the breast and/or nipple against        the breast shield to cause milk to be expressed.    -   Flexible diaphragm is removable from a diaphragm housing portion        of the breast shield for cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   No other parts are removable from the breast shield, apart from        the flexible diaphragm.    -   The milk container attaches to a lower surface of the housing        and forms the base of the breast pump system in use.    -   The milk container mechanically or magnetically latches to the        housing.    -   The milk container is released by the user pressing a button on        the housing.    -   The milk container includes a removable cap and a removable        valve that is seated on the lid.    -   In normal use, the milk container is positioned entirely within        a bra.    -   No other parts are removable from the milk container, apart from        the cap and the valve.    -   All parts that are user-removable in normal use are attached to        either the breast shield or the milk container.    -   Audible or haptic feedback confirms the pump system is properly        assembled for normal use with the milk container locked to the        housing and the breast shield locked to the housing.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 2 Elvie is Wearable and Includes a Clear Breast Shield Giving anUnobstructed View of the Breast for Easy Nipple Alignment

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) and a breast shield including a substantially transparent nippletunnel, shaped to receive a nipple, providing to the mother placing thebreast shield onto her breast a clear and unobstructed view of thenipple when positioned inside the nipple tunnel, to facilitate correctnipple alignment.

Optional:

-   -   The breast shield is configured to provide to the mother a clear        and unobstructed view of the nipple when the breast shield is        completely out, of or separated from, the housing.    -   The breast shield is configured to provide to the mother a clear        and unobstructed view of the nipple when the breast shield is        partially out of, or partially separated from, the housing.    -   Entire breast shield is substantially transparent.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around a        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Housing is configured to slide onto the breast shield, when the        breast shield has been placed onto a breast, using guide        members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers, such as ball bearings in the housing locate        into small indents in the breast shield.    -   Breast shield latches into position against the housing using        magnets.    -   Breast shield includes or operates with a flexible diaphragm        that (a) flexes when negative air pressure is applied to it by        an air pump system in the housing, and (b) transfers that        negative air-pressure to pull the breast and/or nipple against        the breast shield to cause milk to be expressed.    -   Flexible diaphragm is removable from a diaphragm housing portion        of the breast shield for cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   Nipple tunnel includes on its lower surface an opening through        which expressed milk flows.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.    -   A milk container attaches to a lower surface of the housing and        forms the base of the breast pump system in use.    -   The milk container mechanically or magnetically latches to the        housing.    -   The milk container is released by the user pressing a button on        the housing.    -   The milk container includes a removable cap and a removable        valve that is seated on the lid.    -   In normal use, the milk container is positioned entirely within        a bra.

Feature 3 Elvie is Wearable and Includes a Clear Breast Shield withNipple Guides for Easy Breast Shield Sizing

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) and a breast shield including a substantially transparent nippletunnel shaped to receive a nipple, the nipple tunnel including guidelines that define the correct spacing of the nipple from the side wallsof the nipple tunnel.

Optional:

-   -   The guide lines run generally parallel to the sides of the        nipple placed within the nipple tunnel.    -   Breast shield is selected by the user from a set of different        sizes of breast shield to give the correct spacing.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around the        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Housing is configured to slide onto the breast shield, when the        breast shield has been placed onto a breast, using guide        members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers in the housing locate into small indents in the        breast shield.    -   Breast shield latches into position against the housing using        magnets.    -   Breast shield includes or operates with a flexible diaphragm        that (a) flexes when negative air pressure is applied to it by        an air pump system in the housing, and (b) transfers that        negative air-pressure to pull the breast and/or nipple against        the breast shield to cause milk to be expressed.    -   Flexible diaphragm is removable from a diaphragm housing portion        of the breast shield for cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   Nipple tunnel includes on its lower surface an opening through        which expressed milk flows.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 4 Elvie is Wearable and Includes a Breast Shield that AudiblyAttaches to the Housing.

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) and a breast shield that is attachable to the housing with amechanism that latches with an audible click when the breast shield isslid on to or against the housing with sufficient force.

Optional:

-   -   The breast shield is configured to slide onto or against the        housing in a direction parallel to the long dimension of a        nipple tunnel in the breast shield.    -   Breast shield is removable from the housing with an audible        click when the breast shield is pulled away from the housing        with sufficient force.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around the        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Housing is configured to slide onto the breast shield, when the        breast shield has been placed onto a breast, using guide        members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers, such as ball bearings in the housing locate        into small indents in the breast shield.    -   Breast shield latches into position against the housing using        magnets.    -   Breast shield includes or operates with a flexible diaphragm        that (a) flexes when negative air pressure is applied to it by        an air pump system in the housing, and (b) transfers that        negative air-pressure to pull the breast and/or nipple against        the breast shield to cause milk to be expressed.    -   The edge of the flexible diaphragm seals, self-seals,        self-energising seals, or interference fit seals against the        housing when the breast shield attaches to the housing.    -   Flexible diaphragm is removable from a diaphragm housing portion        of the breast shield for cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   Nipple tunnel includes on its lower surface an opening through        which expressed milk flows.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 5 Elvie is Wearable and Includes a Breast Shield that Attachesto the Housing with a Single Push

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) and a breast shield configured to attach to the housing with asingle, sliding push action.

Optional:

-   -   The breast shield is configured to slide onto or against the        housing in a direction parallel to the long dimension of a        nipple tunnel in the breast shield.    -   The single push action overcomes a latching resistance.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around a        nipple inserted into a nipple tunnel in the breast shield to        position a diaphragm housing portion of the breast shield at the        top of the breast.    -   Housing is configured to slide onto the breast shield when the        breast shield has been placed onto a breast using guide members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers, such as ball bearings in the housing locate        into small indents in the breast shield.    -   Breast shield latches into position against the housing using        magnets.    -   Breast shield includes or operates with a flexible diaphragm        that (a) flexes when negative air pressure is applied to it by        an air pump system in the housing, and (b) transfers that        negative air-pressure to pull the breast and/or nipple against        the breast shield to cause milk to be expressed.    -   The edge of the flexible diaphragm seals, self-seals,        self-energising seals, or interference fit seals against the        housing when the breast shield attaches to the housing.    -   Flexible diaphragm is removable from a diaphragm housing portion        of the breast shield for cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   Nipple tunnel includes on its lower surface an opening through        which expressed milk flows.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.    -   A milk container attaches to a lower surface of the housing and        forms the base of the breast pump system in use.    -   The milk container mechanically or magnetically latches to the        housing.    -   The milk container is released by the user pressing a button on        the housing.    -   The milk container includes a removable cap and a removable        valve that is seated on the lid.    -   In normal use, the milk container is positioned entirely within        a bra.

Feature 6 Elvie is Wearable and not Top Heavy, to Ensure Comfort andReliable Suction Against the Breast

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism

(b) and a breast shield;

(c) a milk container;

and in which the centre of gravity of the pump system is, when the milkcontainer is empty, substantially at or below (i) the half-way heightline of the housing or (ii) the horizontal line that passes through anipple tunnel or filling point on a breast shield, so that the device isnot top-heavy for a woman using the pump.

Optional:

-   -   The milk container is a re-useable milk container that when        connected to the housing is positioned to form the base of the        housing.    -   In which the centre of gravity only moves lower during use as        the milk container gradually receives milk, which increases the        stability of the pump inside the bra.    -   In which milk only passes downwards when moving to the milk        container, passing through the nipple tunnel and then through an        opening in the lower surface of the nipple tunnel directly into        the milk container, or components that are attached to the milk        container.    -   System is configured so that its centre of gravity is no more        than 60 mm up from the base of the milk container also below the        top of the user's bra cup.    -   In which the pumping mechanism and the power supply for that        mechanism are positioned within the housing to provide a        sufficiently low centre of gravity.    -   In which the pumping mechanism is one or more piezo air pumps,        and the low weight of the piezo air pumps enables the centre of        gravity to be substantially at or below (i) the half-way height        line of the housing or (ii) the horizontal line that passes        through the nipple tunnel or filling point on the breast shield.    -   In which the pumping mechanism is one or more piezo air pumps,        and the small size of the piezo air pumps enables the components        in the housing to be arranged so that the centre of gravity is        substantially at or below (i) the half-way height line of the        housing or (ii) the horizontal line that passes through the        nipple tunnel or filling point on the breast shield.    -   In which the pumping mechanism is one or more piezo air pumps,        and the low weight of the battery or batteries needed to power        that piezo air pumps enables the centre of gravity to be        substantially at or below (i) the half-way height line of the        housing or (ii) the horizontal line that passes through the        nipple tunnel or filling point on the breast shield.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 7 Elvie is Wearable and has a Night Mode for Convenience

A breast pump system including:

(a) a housing including a pumping mechanism;

(b) an illuminated control panel;

(c) a control system that reduces or adjusts the level or colour ofillumination of the control panel at night or when stipulated by theuser.

Optional:

-   -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   Control system is implemented in hardware in the pump itself        using a ‘night mode’ button.    -   Control system is implemented in software within a connected        device app running on the user's smartphone.    -   Control system is linked to the illumination level on a        connected device app., so that when the connected app is in        ‘night mode’, the illuminated control panel is also in ‘night        mode’, with a lower level of illumination, and when the        illuminated control panel on the housing is in ‘night mode’,        then the connected app is also in ‘night mode’.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast. The pumping mechanism is        one or more piezo air pumps, selected for quiet operation.

Feature 8 Elvie is Wearable and Includes a Haptic or Visual IndicatorShowing when Milk is Flowing or not Flowing Well

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) a milk container that is configured to be concealed within a bra andis hence not visible to the mother in normal use;

(c) a visual and/or haptic indicator that indicates whether milk isflowing or not flowing into the milk container.

Optional:

-   -   A haptic and/or visual indicator indicates if the pump is        operating correctly to pump milk, based on whether the quantity        and/or the height of the liquid in the container above its base        is increasing above a threshold rate of increase    -   The visual indicator is a row of LEDs that changes appearance as        the quantity of liquid increases.    -   The haptic and/or visual indicator provides an indication of an        estimation of the flow rate.    -   The visual indicator provides a colour-coded indication of an        estimation of the flow rate.    -   The visual indicator provides an indication of how much of the        container has been filled.    -   The visual indicator is part of a user interface in a connected,        companion application, running on a smartphone or other personal        device, such as a smart watch or smart ring.    -   The haptic indicator is part of a user interface in a connected,        companion application, running on a smartphone or other personal        device, such as a smart watch or smart ring.    -   A sub-system measures or infers the quantity and/or the height        of the liquid in the container.    -   The sub-system measures or infers the quantity and/or the height        of the liquid in the container by using one or more light        emitters and light detectors to detect light from the emitters        that has been reflected by the liquid, and measuring the        intensity of that reflected light.    -   Sub-system includes or communicates with an accelerometer and        uses a signal from the accelerometer to determine if the liquid        is sufficiently still to permit the sub-system to accurately        measure or infer the quantity and/or the height of the liquid in        the container.    -   A sub-system measures or infers the angle the top surface of the        liquid in the container makes with respect to a baseline, such        as the horizontal.    -   A haptic and/or visual indicator indicates if the amount of milk        in the milk container has reached a preset quantity or level.    -   A haptic and/or visual indicator indicates if there is too much        movement of the breast pump system for viable operation.    -   Milk container is attached to the lower part of the housing and        forms the base of the breast pump system.    -   Milk container is made of transparent material.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 9 Elvie is Wearable and Collects Data to Enable the Mother toUnderstand What Variables (e.g. Time of Day, Pump Speed Etc.) Correlateto Good Milk-Flow

A breast pump system including:

(a) a housing including a pumping mechanism;

(b) a milk container;

(c) a measurement sub-system that measures or infers milk flow into themilk container;

-   -   and in which the measurement sub-system provides data to a data        analysis system that determines metrics that correlate with        user-defined requirements for milk-flow rate or milk expression.

Optional:

-   -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   User-defined requirement is to enhance or increase milk-flow.    -   User-defined requirement is to reduce milk-flow.    -   The data analysis system analyses data such as any of the        following: amount of milk expressed over one or more sessions,        rate at which milk is expressed over one or more sessions,        profile of the rate at which milk is expressed over one or more        sessions.    -   The data analysis system determines metrics such as any of the        following: pump speed, length of a single pumping session,        negative air pressure or vacuum level, peak negative air        pressure or vacuum level, pump cycle time or frequency, changing        profile of pump speed over a single pumping session time of day.    -   The data analysis system determines metrics such as any of the        following: amount and type of liquids consumed by the mother,        state of relaxation of the mother before or during a session,        state of quiet experienced by the mother before or during a        session, what overall milk expression profile the mother most        closely matches.    -   Data analysis system is local to the breast pump system, or runs        on a connected device, such as a smartphone, or is on a remote        server or is on the cloud, or is any combination of these.    -   measurement sub-system measures or infers the quantity and/or        the height of the liquid in the container above its base.    -   Measurement sub-system measures or infers angle the top surface        of the liquid in the container makes with respect to a baseline,        such as the horizontal.    -   Data analysis system gives recommended metrics for improving        milk flow    -   Data analysis system gives recommended metrics for weaning.    -   Data analysis system gives recommended metrics for increasing        milk supply (e.g. power pumping).    -   Data analysis system gives recommended metrics if an optimal        session start time or a complete session has been missed.    -   Data analysis system leads to automatic setting of metrics for        the pumping mechanism, such as pump speed, length of a single        pumping session, vacuum level, cycle times, changing profile of        pump speed over a single pumping session.    -   Data analysis system enables sharing across large numbers of        connected devices or apps information that in turn optimizes the        milk pumping or milk weaning efficacy of the breast pump.    -   Metrics include the specific usage of the connected device by a        woman while using the pump (for example by the detection of        vision and/or audio cues).    -   The measurement sub-system measures or infers the quantity        and/or the height of the liquid in the container.    -   The measurement sub-system measures or infers the quantity        and/or the height of the liquid in the container by using one or        more light emitters and light detectors to detect light from the        emitters that has been reflected by the liquid, and measuring        the intensity of that reflected light.    -   The measurement sub-system includes or communicates with an        accelerometer and uses a signal from the accelerometer to        determine if the liquid is sufficiently still to permit the        measurement sub-system to accurately measure or infer the        quantity and/or the height of the liquid in the container.    -   Milk container is a re-useable milk container that when        connected to the housing is positioned to form the base of the        housing.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 10 Elvie is Wearable and Collects Data that can be Exported toSocial Media.

A breast pump system including:

(a) a housing including a pumping mechanism;

(b) a milk container;

(c) a data sub-system that collects and provides data to a connecteddevice or remote application or remote server;

(d) and in which the collected data, in whole or in part, is used by adata analysis system that provides inputs to a social media or communityfunction or platform.

Optional:

-   -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   The data analysis system analyses metrics such as any of the        following: amount of milk expressed over one or more sessions,        rate at which milk is expressed over one or more sessions,        profile of the rate at which milk is expressed over one or more        sessions.    -   The data analysis system analyses metrics such as any of the        following: pump speed, length of a single pumping session,        negative air pressure or vacuum level, peak negative air        pressure or vacuum level, pump cycle time or frequency, changing        profile of pump speed over a single pumping session time of day.    -   The data analysis system analyses metrics such as any of the        following: amount and type of liquids consumed by the mother,        state of relaxation of the mother before or during a session,        state of quiet experienced by the mother before or during a        session, what overall milk expression profile the mother most        closely matches.    -   Data analysis system is local to the breast pump system, or runs        on a connected device, such as a smartphone, or is on a remote        server or is on the cloud, or is any combination of these.    -   The social media or community function or platform organizes the        collected data into different profiles.    -   The social media or community function or platform enables a        user to select a matching profile from a set of potential        profiles.    -   each profile is associated with a specific kind of milk        expression profile, and provides information or advice that is        specifically relevant to each milk expression profile.    -   Information or advice includes advice on how to increase milk        expression by varying parameters, such as time of milk        expression, frequency of a milk expression session, pump speed,        length of a single pumping session, vacuum level, cycle times,        changing profile of pump speed over a single pumping session and        any other parameter that can be varied by a mother to help her        achieve her milk expression goals.    -   The application is connected to other applications residing on        the connected device, such as a fitness app.    -   The collected data includes data received from other connected        apps.    -   The collected data is anonymized before it is shared.    -   The sub-system includes a wi-fi connectivity component for        direct connectivity to a remote server.    -   The milk container is a re-useable milk container that when        connected to the housing is positioned to form the base of the        housing.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 11 Elvie is Wearable and has a Smart Bottle that Stores the Timeand/or Date of Pumping to Ensure the Milk is Used when Fresh

A breast pump system including a pumping mechanism and a milk containerand including:

(a) a housing including the pumping mechanism;

(b) a milk container;

(c) and in which the milk container or any associated part, such as alid, includes a memory or tag that is automatically programmed to storethe time and/or date it was filled with milk.

Optional:

-   -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   Memory or tag is programmed to store the quantity of milk in the        milk container.    -   Memory or tag stores the milk expiry date.    -   Memory or tag stores a record of the temperature of the milk or        the ambient temperature around the milk, and calculates an        expiry date using that temperature record.    -   System includes a clock and writes the time and/or date the milk        container was filled with milk to the memory or tag on the milk        container.    -   Clock is in the housing.    -   Clock is in the milk container.    -   Milk container includes a display that shows the time and/or        date it was filled with milk.    -   Milk container includes a display that shows the quantity of        milk that it was last filled with milk.    -   Milk container includes a display that shows whether the left or        right breast was used to fill the milk container.    -   Memory or tag is connected to a data communications sub-system.    -   Memory or tag is a remotely readable memory or tag, such as a        NFC tag, enabling a user to scan the milk container with a        reader device, such as a smartphone, and have the time and/or        date that container was filled with milk, displayed on the        reader device.    -   Reader device shows the time and/or date a specific milk        container was filled with milk.    -   Reader device shows the quantity of milk that a specific milk        container was last filled with.    -   Reader device shows the time and/or date and/or quantity that        each of several different milk containers were filled with.    -   Reader device shows whether the left or right breast was used to        fill the milk contained in a specific milk container.    -   A sub-system measures or infers milk flow into the milk        container.    -   The sub-system measures or infers the quantity and/or the height        of the liquid in the container.    -   The sub-system measures or infers the quantity and/or the height        of the liquid in the container by using one or more light        emitters and light detectors to detect light from the emitters        that has been reflected by the liquid, and measuring the        intensity of that reflected light.    -   Sub-system includes an accelerometer and uses a signal from the        accelerometer to determine if the liquid is sufficiently still        to permit the sub-system to accurately measure or infer the        quantity and/Tr the height of the liquid in the container.    -   The sub-system is in the housing.    -   Milk container is a re-useable milk container that when        connected to the housing is positioned to form the base of the        housing.    -   Pumping mechanism is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 12 a Smart Bottle that Stores the Time and/or Date of Pumping toEnsure the Milk is Used when Fresh.

A smart bottle or container that includes or is associated with a memoryor a tag that is programmed to store the date and time it is filledusing data from a pump or a connected device, such as a smartphone.

Optional:

-   -   The container includes wireless connectivity and connects to a        companion app.    -   The memory or tag includes an NFC chip and is read using a NFC        reader.    -   The memory or tag stores also an expiry date.    -   Memory or tag stores a record of the temperature of the milk or        the ambient temperature around the milk, and calculates an        expiry date using that temperature record.    -   The memory or tag stores also the quantity of milk stored.    -   System includes a clock and writes the time and/or date the milk        container was filled with milk to the memory or tag on the milk        container.    -   Clock is in the housing.    -   Clock is in the container.    -   Milk container includes a display that shows the time and/or        date it was filled with milk.    -   Milk container includes a display that shows the quantity of        milk that it was last filled with milk.    -   Milk container includes a display that shows whether the left or        right breast was used to fill the milk contained.    -   Milk container includes a display that shows the expiry date.    -   memory or tag is connected to a data communications sub-system.    -   Memory or tag is a remotely readable memory or tag, such as a        NFC tag, enabling a user to scan the milk container with a        reader device, such as a smartphone.    -   Reader device shows the time and/or date a specific milk        container was filled with milk.    -   Reader device shows the quantity of milk that a specific milk        container was last filled with.    -   Reader device shows the time and/or date and/or quantity that        each of several different containers were filled with.    -   Reader device shows whether the left or right breast was used to        fill the milk contained in a specific milk container.    -   Reader device shows the expiry date.    -   Container includes wireless connectivity and connects to a        companion application.    -   An application tracks status of one or more smart containers and        enables a user to select an appropriate smart container for a        feeding session.    -   The pump is wearable.    -   The pump is in a housing shaped to fit inside a bra and the        container is a milk container that is connected to the housing        and is positioned to form the base of the housing.    -   Container is used for liquids other than milk.

Feature 13 Elvie is Wearable and Includes a Sensor to Infer the Amountof Movement or Tilt Angle During Normal Use.

A breast pump system including:

(a) a housing;

(b) a milk container;

(c) the housing including a sensor, such as an accelerometer, thatmeasures or determines the movement and/or tilt angle of the housing,during a pumping session and automatically affects or adjusts theoperation of the system depending on the output of the sensor.

Optional:

-   -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   If the tilt angle of the housing exceeds a threshold, then the        system automatically affects the operation of the system by        warning or alerting the mother of a potential imminent spillage        (e.g. from milk flowing back out of a breast shield) using an        audio, or visual or haptic alert, or a combination of audio,        haptic and visual alerts.    -   If the tilt angle of the housing exceeds a threshold, then the        system automatically adjusts the operation of the system by        stopping the pump to prevent spillage.    -   When the tilt angle of the housing reduces below the threshold,        the system automatically adjusts the operation of the system by        causing pumping to resume automatically.    -   If the tilt angle of the housing exceeds a threshold, then the        system automatically affects the operation of the system by        providing the mother with an alert to change position.    -   The container includes an optically clear region.    -   There are one or more light emitters and detectors positioned in        the base of the housing, the light emitters and receivers        operating as part of a sub-system that measures or infers the        tilt angle of the milk in the container.    -   The sub-system measures the quantity of liquid in the milk        container and also takes the measured tilt angle of the housing        into account.    -   If the tilt angle is above a certain threshold, the system        ignores the quantity of liquid measured.    -   The sub-system derives or infers the mother's activity, such as        walking, standing or lying activities, from the sensor.    -   The milk container is a re-useable milk container that when        connected to the housing is positioned to form the base of the        housing.    -   Sub-system stores a time-stamped record of movement and/or tilt        angles of the housing in association with milk flow data.    -   System includes a breast shield that attaches to the housing.    -   System includes a closed loop negative air-pressure system that        applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 14 Elvie Includes a Control to Toggle Between Recording WhetherMilk is being Expressed from the Left Breast and the Right Breast.

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra;

(b) a control interface that the user can select to indicate or recordif milk is being expressed from the left or the right breast.

Optional:

-   -   Control interface is a physical interface on the housing.    -   Control interface is a single button on the housing.    -   Control interface is from an application running on a device,        such as a smartphone or smart ring.    -   Visual indicators on the housing indicate whether the breast        pump system is being set up the left or the right breast.    -   The visual indicator for the left breast is on the right-hand        side of the housing, when viewed from the front; and the visual        indicator for the right breast is on the left-hand side of the        housing, when viewed from the front.    -   The housing includes a button labeled to indicate the left        breast and a button labeled to indicate the right breast, that        are respectively illuminated to indicate from which breast the        milk is being expressed.    -   Breast pump system is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 15 Elvie Includes a Pressure Sensor.

A breast pump system including (i) a pumping mechanism that appliesnegative air-pressure and (ii) an air pressure sensor configured tomeasure the negative pressure delivered by the negative air-pressuremechanism and (iii) a measurement sub-system that measures or infersmilk flow or milk volume.

Optional:

-   -   The system also includes a control sub-system that combines or        relates the air-pressure measurements with the milk flow or milk        volume measurements    -   The control sub-system automatically adjusts the negative        air-pressure to give the optimal milk flow or milk volume.    -   The control sub-system automatically adjusts the negative        air-pressure during a pumping session to give the optimal milk        flow or milk volume within comfort constraints defined by the        user.    -   The air pressure sensor detects pressure created by the pumping        mechanism.    -   Sensor is a piezo air pressure sensor    -   Air pressure sensor measures the negative air pressure during a        normal milk expression session.    -   Air pressure sensor measures the negative air pressure during a        calibration session, and the system uses the results to vary the        operation of the pumping mechanism so that it deliver consistent        performance over time.    -   Air pressure sensor measures the negative air pressure during a        calibration session, and the system uses the results to vary the        operation of the pumping mechanism so that different pumping        mechanisms in different breast pump systems all deliver        consistent performance    -   Air pressure sensor measures the negative air pressure during a        calibration session, and the system uses the results to        determine if the pumping mechanism is working correctly, within        tolerance levels.    -   The operation of the pumping mechanism is varied by altering the        duty or pump cycle.    -   The operation of the pumping mechanism is varied by altering the        voltage applied to the pumping mechanism.    -   Pumping mechanism is a piezo air pump.    -   Piezo air pump forms part of a closed or closed loop system.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a flexible diaphragm that        seals, self-seals, self-energising seals or interference fit        seals against a diaphragm housing that forms part of a breast        shield.    -   Breast pump system is wearable and includes a housing that is        shaped at least in part to fit inside a bra.    -   Breast pump system includes a milk container and a measurement        sub-system that automatically measures the quantity of milk in        the milk container.    -   The measurement sub-system includes one or more light emitters        and one or more light detectors, operating as part of a        sub-system that measures or infers the quantity of the milk in        the container and/or the height of the milk in the container        above its base, and in which the light detectors detect and        measure the intensity of the light from the emitters that has        been reflected from the surface of the milk.

Feature 16 Elvie Includes a Microcontroller to Enable Fine TuningBetween Pre-Set Pressure Profiles

A breast pump system including (i) a pumping mechanism that appliesnegative air-pressure and (ii) a microcontroller programmed to cause thepumping mechanism to deliver various pre-set pressure profiles and topermit the user to manually vary the pressure to a value or values thatare in-between the values available from a pre-set pressure profile.

Optional:

-   -   The user manually varies the pressure using a control interface        on a housing of the breast pump system    -   The user manually varies the pressure using a control interface        on an application running on a wireless device such as a        smartphone that is wirelessly connected to the breast pump        system.    -   The user manually varies the pressure by altering a control        parameter of the pumping mechanism.    -   The user manually varies the pressure by altering the duty cycle        or timing of the pumping mechanism.    -   The user manually varies the pressure by altering the voltage        applied to the pumping mechanism.    -   The system includes an air pressure sensor configured to measure        the negative air pressure delivered by the pumping mechanism.    -   The air pressure sensor is a piezo air pressure sensor.    -   Pumping mechanism is a piezo air pump.    -   Piezo air pump forms part of a closed or closed loop system.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a flexible diaphragm that        seals, self-seals, self-energising seals or interference fit        seals against a diaphragm housing that forms part of a breast        shield.    -   Pressure profile defines one or more maximum negative air        pressure levels.    -   Pressure profile defines one or more maximum negative air        pressure levels, each for a pre-set time.    -   Pressure profile defines one or more cycle time.    -   Pressure profile defines peak flow rate.    -   Breast pump system is wearable and includes a housing that is        shaped at least in part to fit inside a bra.    -   Breast pump system includes a milk container and a measurement        sub-system that automatically measures the quantity of milk in        the milk container.    -   The measurement sub-system includes one or more light emitters        and one or more light detectors, operating as part of a        sub-system that measures or infers the quantity of the milk in        the container and/or the height of the milk in the container        above its base, and in which the light detectors detect and        measure the intensity of the light from the emitters that has        been reflected from the surface of the milk.

Feature 17 Elvie Enables a User to Set the Comfort Level they areExperiencing

A breast pump system including (i) a pumping mechanism that appliesnegative air-pressure and (ii) a microcontroller programmed to controlthe pumping mechanism and to permit the user to manually indicate thelevel of comfort that they are experiencing when the system is in use.

Optional:

-   -   The user manually indicates the level of comfort that they are        experiencing using a touch or voice-based interface on a housing        of the breast pump system    -   The user manually indicate the level of comfort that they are        experiencing using a touch or voice-based interface on an        application running on a wireless device, such as a smartphone,        that is wirelessly connected to the breast pump system.    -   The system stores user-indicated comfort levels together with        associated parameters of the pumping system.    -   The system is a connected device and a remote server stores        user-indicated comfort levels together with associated        parameters of the pumping system.    -   The parameters of the pumping system include one or more of:        pumping strength, peak negative air pressure; flow rate; voltage        applied to the pumping mechanism; duty or timing cycle of the        pumping mechanism.    -   System automatically varies parameters of the pumping system and        then enables the user to indicate which parameters are        acceptable.    -   System includes an air pressure sensor that measures the        negative air pressure delivered by the pumping mechanism.    -   The air pressure sensor is a piezo air pressure sensor.    -   Pumping mechanism is a piezo air pump.    -   Piezo air pump forms part of a closed or closed loop system.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a flexible diaphragm that        seals, self-seals, self-energising seals or interference fit        seals against a diaphragm housing that forms part of a breast        shield.    -   Breast pump system is wearable and includes a housing that is        shaped at least in part to fit inside a bra.    -   Breast pump system includes a milk container and a measurement        sub-system that automatically measures the quantity of milk in        the milk container.    -   The measurement sub-system includes one or more light emitters        and one or more light detectors, operating as part of a        sub-system that measures or infers the quantity of the milk in        the container and/or the height of the milk in the container        above its base, and in which the light detectors detect and        measure the intensity of the light from the emitters that has        been reflected from the surface of the milk.

Feature 18 Elvie Includes a Microcontroller to Dynamically andAutomatically Alter Pump Operational Parameters

A breast pump system including (i) a pumping mechanism that appliesnegative air-pressure and (ii) a microcontroller programmed toautomatically change one or more parameters of the pumping mechanism,and to automatically measure or relate milk expression data as afunction of different values of one or more of these parameters.

Optional:

-   -   The milk expression data includes one or more of the following:        milk expression rate or quantity; comfort; optimal pumping mode;        optimal pumping mode given remaining battery power.    -   The system automatically calculates or identifies the parameters        of the pumping mechanism that correlate with maximum milk        expression rate or quantity and uses that set of parameters.    -   The system automatically calculates or identifies the parameters        of the pumping mechanism that correlate with maximum milk        expression rate or quantity and uses that set of parameters if        the comfort experienced by the user when those parameters are        used is above a threshold.    -   The system displays the parameters of the pumping mechanism that        correlate with maximum milk expression rate or quantity to the        user.    -   The system displays the parameters of the pumping mechanism that        correlate with maximum milk expression rate or quantity to the        user and enables the user to manually select those parameters if        they are acceptable.    -   Parameters of the pumping mechanism includes pumping strength,        peak negative air pressure; flow rate; voltage applied to the        pumping mechanism; duty or timing cycle of the pumping        mechanism.    -   System includes an air pressure sensor that measures the        negative air pressure delivered by the pumping mechanism.    -   The air pressure sensor is a piezo air pressure sensor.    -   Pumping mechanism is a piezo air pump.    -   Piezo air pump forms part of a closed or closed loop system.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a flexible diaphragm that        seals, self-seals, self-energising seals or interference fit        seals against a diaphragm housing that forms part of a breast        shield.    -   Breast pump system is wearable and includes a housing that is        shaped at least in part to fit inside a bra.    -   Breast pump system includes a milk container and a measurement        sub-system that automatically measures the quantity of milk in        the milk container.    -   The measurement sub-system includes one or more light emitters        and one or more light detectors, operating as part of a        sub-system that measures or infers the quantity of the milk in        the container and/or the height of the milk in the container        above its base, and in which the light detectors detect and        measure the intensity of the light from the emitters that has        been reflected from the surface of the milk.

Feature 19 Elvie Automatically Learns the Optimal Conditions forLet-Down

A breast pump system including (i) a pumping mechanism that appliesnegative air-pressure and (ii) a microcontroller programmed todynamically change one or more parameters of the pumping mechanism, andto automatically detect the start of milk let-down.

Optional:

-   -   The microcontroller is programmed to dynamically change one or        more parameters of the pumping mechanism, to enable it to learn        or optimize the parameters relating to milk let-down.    -   The system automatically calculates or identifies or learns the        parameters of the pumping mechanism that correlate with the        quickest start of milk let-down.    -   The system automatically calculates or identifies or learns the        parameters of the pumping mechanism that correlate with the        quickest start of milk let-down and uses that set of parameters        if the comfort experienced by the user when those parameters are        used is above a threshold or are otherwise acceptable to the        user.    -   The system displays the parameters of the pumping mechanism that        correlate with the quickest start of milk let-down to the user.    -   The system displays the parameters of the pumping mechanism that        correlate with the quickest start of milk let-down and enables        the user to manually select those parameters if they are        acceptable.    -   parameters of the pumping mechanism includes pumping strength,        peak negative air pressure; flow rate; voltage applied to the        pumping mechanism; duty or timing cycle of the pumping        mechanism.    -   System includes an air pressure sensor that measures the        negative air pressure delivered by the pumping mechanism.    -   The air pressure sensor is a piezo air pressure sensor.    -   Pumping mechanism is a piezo air pump.    -   Piezo air pump forms part of a closed or closed loop system.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a flexible diaphragm that        seals, self-seals, self-energising seals or interference fit        seals against a diaphragm housing that forms part of a breast        shield.    -   Breast pump system is wearable and includes a housing that is        shaped at least in part to fit inside a bra.    -   Breast pump system includes a milk container and a measurement        sub-system that automatically measures the quantity of milk in        the milk container.    -   The measurement sub-system includes one or more light emitters        and one or more light detectors, operating as part of a        sub-system that measures or infers the quantity of the milk in        the container and/or the height of the milk in the container        above its base, and in which the light detectors detect and        measure the intensity of the light from the emitters that has        been reflected from the surface of the milk.

B. Elvie Piezo Air Pump Feature Cluster

Feature 20 Elvie is Wearable and has a Piezo Air-Pump for QuietOperation

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra;

(b) a piezo air-pump in the housing that is part of a closed loop systemthat drives, a separate, deformable diaphragm to generate negative airpressure.

Optional:

-   -   The deformable diaphragm inside the housing is driven by        negative air pressure generated by the piezo pump.    -   Piezo air pump is positioned at or close to the base of the        housing.    -   There are two or more piezo air pumps.    -   There are two or more piezo air pumps mounted in a series        arrangement.    -   There are two or more piezo air pumps mounted in a parallel        arrangement.    -   The closed system is separated from a ‘milk’ side by a flexible        diaphragm.    -   Deformable diaphragm is removably mounted against a part of a        breast shield.    -   Deformable diaphragm is a unitary or one-piece object that is        removably mounted against a part of a breast shield.    -   Deformable diaphragm is not physically connected to the piezo        air-pump.    -   Piezo air-pump is a closed loop air-pump that drives a        physically separate and remote deformable diaphragm that        removably fits directly onto the breast shield    -   Deformable diaphragm is a flexible generally circular diaphragm        that sits over a diaphragm housing that is an integral part of a        breast shield.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   The piezo pump delivers in excess of 400 mBar (40 kPa) stall        pressure and 1.5 litres per minute free air flow.    -   The piezo air pump weighs less than 10 gm, and may weigh less        than 6 gm.    -   In operation, the breast pump system makes less then 30 dB noise        at maximum power and less than 25 dB at normal power, against a        20 dB ambient noise.    -   In operation, the breast pump system makes approximately 24 dB        noise at maximum power and 22 dB at normal power, against a 20        dB ambient noise.    -   The piezo pump is fed by air that passes through an air filter.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 21 Elvie has a Piezo Air-Pump and Self-Sealing Diaphragm

A breast pump system including:

(a) a housing;

(b) a piezo air-pump in the housing that is part of a closed loop systemthat drives, a physically separate, deformable, self-sealing diaphragm,to generate negative air pressure.

Optional:

-   -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   Piezo air pump is positioned at or close to the base of the        housing.    -   There are two or more piezo air pumps.    -   There are two or more piezo air pumps mounted in a series        arrangement.    -   There are two or more piezo air pumps mounted in a parallel        arrangement.    -   The closed system is separated from a ‘milk’ side by the        flexible diaphragm.    -   Deformable diaphragm is removably mounted against a part of a        breast shield.    -   Deformable diaphragm is a unitary or one-piece object that is        removably mounted against a part of a breast shield.    -   Deformable diaphragm is not physically connected to the piezo        air-pump.    -   Piezo air-pump is a closed loop air-pump that drives a        physically separate and remote deformable diaphragm that        removably fits directly onto the breast shield.    -   Deformable diaphragm is a flexible generally circular diaphragm        that sits over a diaphragm housing that is an integral part of a        breast shield.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   The piezo pump delivers in excess of 400 mBar (40 kPa) stall        pressure and 1.5 litres per minute free air flow.    -   The piezo air pump weighs less than 10 gm, and may weigh less        than 6 gm.    -   In operation, the breast pump system makes less then 30 dB noise        at maximum power and less than 25 dB at normal power, against a        20 dB ambient noise.    -   In operation, the breast pump system makes approximately 24 dB        noise at maximum power and 22 dB at normal power, against a 20        dB ambient noise.    -   The piezo pump is fed by air that passes through an air filter.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.

Feature 22 Elvie Uses More than One Piezo Air Pump in Series

A breast pump system including:

(a) a housing;

(b) multiple piezo air-pumps in the housing that drives a deformablediaphragm inside the housing to generate negative air pressure; in whichthe multiple piezo air-pumps can be operated at different times inseries-connected and in parallel-connected modes.

Optional:

-   -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   Parallel connected mode is used during a first part of a pumping        cycle to reach a defined negative air pressure more quickly than        series connected mode would, and then the system switches to a        series connected mode to reach a greater negative air pressure        than series connected mode can reach.    -   An actuator switches the system from parallel-connected piezo        pump mode to series-connected piezo pump mode.    -   Each piezo pump delivers in excess of 400 mBar (40 kPa) stall        pressure and 1.5 litres per minute free air flow.    -   Each piezo air pump weighs less than 10 gm, and may weigh less        than 6 gm.    -   In operation, the breast pump system makes less then 30 dB noise        at maximum power and less than 25 dB at normal power, against a        20 dB ambient noise.    -   In operation, the breast pump system makes approximately 24 dB        noise at maximum power and 22 dB at normal power, against a 20        dB ambient noise.    -   Each piezo pump is fed by air that passes through an air filter.    -   Each piezo air pump forms part of a closed or closed loop        system.    -   Each piezo air pump is positioned at or close to the base of the        housing.    -   There are two or more piezo air pumps.    -   The piezo-air pumps are a closed loop negative air-pressure        system that applies negative pressure to a region surrounding a        woman's breast to pump milk form that breast.    -   The piezo air-pump is a closed loop negative air-pressure system        that drives a physically separate and remote deformable,        self-sealing diaphragm that removably fits directly onto the        breast shield.

Feature 23 Elvie is Wearable and has a Piezo Air-Pump, a Breast Shieldand a Diaphragm that Fits Directly onto the Breast Shield

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra;

(b) a breast shield that attaches to the housing;

(b) a piezo air-pump in the housing that drives a deformable diaphragmthat fits directly onto the breast shield.

Optional:

-   -   Deformable diaphragm is a flexible generally circular diaphragm        that sits over a diaphragm housing that is an integral part of a        breast shield.    -   Deformable diaphragm is removable from the diaphragm housing for        cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   Piezo air pump forms part of a closed or closed loop system.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.    -   The piezo air-pump is a closed loop negative air-pressure system        that drives a physically separate and remote deformable,        self-sealing diaphragm that removably fits directly onto the        breast shield.    -   Piezo air pump is position at or close to the base of the        housing.    -   There are two or more piezo air pumps.    -   There are two or more piezo air pumps mounted in a series        arrangement.    -   There are two or more piezo air pumps mounted in a parallel        arrangement.    -   The piezo pump delivers in excess of 400 mBar (40 kPa) stall        pressure and 1.5 litres per minute free air flow.    -   The piezo air pump weighs less than 10 gm, and may weigh less        than 6 gm.    -   In operation, the breast pump system makes less then 30 dB noise        at maximum. power and less than 25 dB at normal power, against a        20 dB ambient noise.    -   In operation, the breast pump system makes approximately 24 dB        noise at maximum power and 22 dB at normal power, against a 20        dB ambient noise. The piezo pump is fed by air that passes        through an air filter.    -   The breast shield and milk container are each pressed or pushed        into engagement with the housing.    -   The breast shield and milk container are each pressed or pushed        into a latched engagement with the housing.    -   The breast shield and milk container are each insertable into        and removable from the housing using an action confirmed with an        audible sound, such as a click.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast and a nipple tunnel shaped        to receive a nipple.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around a        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Breast shield slides into the housing using guide members.    -   Housing is configured to slide onto the breast shield, when the        breast shield has been placed onto a breast, using guide        members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers, such as ball bearings in the housing locate        into small indents in the breast shield.

Feature 24 Elvie is Wearable and has a Piezo Air-Pump for QuietOperation and a Re-Useable, Rigid Milk Container for Convenience

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra;

(b) a piezo air-pump in the housing;

(c) and a re-useable, rigid or non-collapsible milk container that whenconnected to the housing forms an integral part of the housing and thatis also removable from the housing.

Optional:

-   -   Piezo air pump forms part of a closed or closed loop system.    -   Piezo air pump is positioned at or close to the base of the        housing.    -   There are two or more piezo air pumps.    -   There are two or more piezo air pumps mounted in a series        arrangement.    -   There are two or more piezo air pumps mounted in a parallel        arrangement.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.    -   The closed system is separated from a ‘milk’ side by a flexible        diaphragm.    -   A deformable diaphragm inside the housing is driven by negative        air pressure generated by the piezo pump.    -   The piezo air-pump is a closed loop negative air-pressure system        that drives a physically separate and remote deformable,        self-sealing diaphragm that removably fits directly onto the        breast shield.    -   The deformable diaphragm is a flexible generally circular        diaphragm that sits over a diaphragm housing that is an integral        part of a breast shield.    -   The deformable diaphragm is removable from the diaphragm housing        for cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   Nipple tunnel in the breast shield includes an opening on its        lower surface that is positioned through which expressed milk        flows directly into the milk container.    -   The piezo pump delivers in excess of 400 mBar (40 kPa) stall        pressure and 1.5 litres per minute free air flow.    -   The piezo air pump weighs less than 10 gm, and may weigh less        than 6 gm.    -   In operation, the breast pump system makes less then 30 dB noise        at maximum power and less than 25 dB at normal power, against a        20 dB ambient noise.    -   In operation, the breast pump system makes approximately 24 dB        noise at maximum power and 22 dB at normal power, against a 20        dB ambient noise.    -   The milk container forms the base of the system.    -   The milk container has a flat base so that it can rest stably on        a surface.    -   The milk container is removable from the housing.    -   The milk container includes a clear or transparent wall or        section to show the amount of milk collected.    -   The milk container is sealable for storage.    -   The milk container obviates the need for consumable or        replaceable milk pouches.

Feature 25 Elvie has a Piezo-Pump for Quiet Operation and is a ConnectedDevice

A breast pump system including

(a) a housing;

(b) a piezo air-pump in the housing;

(c) a milk container;

(d) a data connectivity module that enables data collection relating tothe operation of the piezo air-pump and transmission of that data to adata analysis system.

Optional:

-   -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   Transmission is to an application running on a connected device        such as a smartphone, or a server, or the cloud.    -   The data collection and transmission relates to any other        operational data of the system.    -   Piezo air pump forms part of a closed or closed loop system.    -   Piezo air pump is positioned at or close to the base of the        housing.    -   There are two or more piezo air pumps.    -   There are two or more piezo air pumps mounted in a series        arrangement.    -   There are two or more piezo air pumps mounted in a parallel        arrangement.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.    -   The piezo air-pump is a closed loop negative air-pressure system        that drives a physically separate and remote deformable,        self-sealing diaphragm that removably fits directly onto the        breast shield.    -   The closed system is separated from a ‘milk’ side by a flexible        diaphragm.    -   A deformable diaphragm inside the housing is driven by negative        air pressure generated by the piezo pump.    -   The deformable diaphragm is a flexible generally circular        diaphragm that sits over a diaphragm housing that is an integral        part of a breast shield.    -   Deformable diaphragm is removable from the diaphragm housing for        cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   Nipple tunnel in the breast shield includes an opening on its        lower surface that is positioned through which expressed milk        flows directly into the milk container.    -   The piezo pump delivers in excess of 400 mBar (40 kPa) stall        pressure and 1.5 litres per minute free air flow.    -   The piezo air pump weighs less than 10 gm, and may weigh less        than 6 gm.    -   In operation, the breast pump system makes less then 30 dB noise        at maximum power and less than 25 dB at normal power, against a        20 dB ambient noise.    -   In operation, the breast pump system makes approximately 24 dB        noise at maximum power and 22 dB at normal power, against a 20        dB ambient noise.    -   A sub-system measures or infers the quantity and/or the height        of the liquid in the container and shares that data with the        data connectivity module.    -   The sub-system measures or infers the quantity and/or the height        of the liquid in the container by using one or more light        emitters and light detectors to detect light from the emitters        that has been reflected by the liquid, and measuring the        intensity of that reflected light.    -   Sub-system includes an accelerometer and uses a signal from the        accelerometer to determine if the liquid is sufficiently still        to permit the sub-system to accurately measure or infer the        quantity and/or the height of the liquid in the container.    -   The data analysis system analyses metrics such as any of the        following: amount of milk expressed over one or more sessions,        rate at which milk is expressed over one or more sessions,        profile of the rate at which milk is expressed over one or more        sessions.    -   The data analysis system analyses metrics such as any of the        following: pump speed, length of a single pumping session,        negative air pressure or vacuum level, peak negative air        pressure or vacuum level, pump cycle time or frequency, changing        profile of pump speed over a single pumping session time of day.    -   The data analysis system analyses metrics such as any of the        following: amount and type of liquids consumed by the mother,        state of relaxation of the mother before or during a session,        state of quiet experienced by the mother before or during a        session, what overall milk expression profile the mother most        closely matches.

Feature 26 Elvie Uses a Piezo in Combination with a Heat Sink thatManages the Heat Produced by the Pump.

A breast pump system including:

(a) a housing;

(b) a piezo air-pump in the housing that drives a deformable diaphragminside the housing to generate negative air pressure;

(c) a heat sink to manage the heat produced by the piezo-air pump toensure it can be worn comfortably.

Optional:

-   -   The heat sink is configured to ensure that the maximum        temperature of any parts of the breast pump system that might        come into contact with the skin, especially prolonged contact        for greater than 1 minute, are no more than 48° C. and        preferably no more than 43° C.    -   The breast pump is wearable and the housing is shaped at least        in part to fit inside a bra.    -   Heat sink is connected to an air exhaust so that air warmed by        the piezo pumps vents to the atmosphere.    -   Heat sink warms a breast shield.    -   Piezo air pump forms part of a closed or closed loop system.    -   Piezo air pump is positioned at or close to the base of the        housing.    -   There are two or more piezo air pumps.    -   There are two or more piezo air pumps, each connected to its own        or a shared heat sink.    -   There are two or more piezo air pumps mounted in a series        arrangement.    -   There are two or more piezo air pumps mounted in a parallel        arrangement.    -   The piezo-air pump is a closed loop negative air-pressure system        that applies negative pressure to a region surrounding a woman's        breast to pump milk form that breast.    -   The piezo air-pump is a closed loop negative air-pressure system        that drives a physically separate and remote deformable,        self-sealing diaphragm that removably fits directly onto the        breast shield.    -   The closed system is separated from a ‘milk’ side by a flexible        diaphragm.    -   A deformable diaphragm inside the housing is driven by negative        air pressure generated by the piezo pump.    -   The deformable diaphragm is a flexible generally circular        diaphragm that sits over a diaphragm housing that is an integral        part of a breast shield.    -   The deformable diaphragm is removable from the diaphragm housing        for cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   Nipple tunnel in the breast shield includes an opening on its        lower surface that is positioned through which expressed milk        flows directly into the milk container.    -   The piezo pump delivers in excess of 400 mBar (40 kPa) stall        pressure and 1.5 litres per minute free air flow.    -   The piezo air pump weighs less than 10 gm, and may weigh less        than 6 gm.    -   In operation, the breast pump system makes less then 30 dB noise        at maximum power and less than 25 dB at normal power, against a        20 dB ambient noise.    -   In operation, the breast pump system makes approximately 24 dB        noise at maximum power and 22 dB at normal power, against a 20        dB ambient noise.

Feature 27 Elvie is Wearable and Gently Massages a Mother's Breast UsingSmall Bladders Inflated by Air from its Negative Pressure Air-Pump

A breast pump system including:

(a) a housing;

(b) an air-pump in the housing that drives a closed loop negativeair-pressure system that applies negative pressure to a regionsurrounding a woman's breast to pump milk form that breast;

(c) in which the air pump also provides air to regularly or sequentiallyinflate one or more air bladders or liners that are configured tomassage one or more parts of the breast.

Optional:

-   -   Air-pump is a piezo pump.    -   Breast pump system is wearable and the housing is shaped at        least in part to fit inside a bra.    -   Bladders or liners are formed in a breast shield that attaches        to the housing.

Feature 28 Elvie is Wearable and Gently Warms a Mother's Breast UsingSmall Chambers Inflated by Warm Air from its Negative Pressure Air-Pump

A breast pump system including:

(a) a housing;

(b) an air-pump, such as a piezo pump, in the housing that drive aclosed loop negative air-pressure system that applies negative pressureto a region surrounding a woman's breast to pump milk form that breast;

(c) in which the air pump also provides warm air to regularly orsequentially inflate one or more air chambers that are configured toapply warmth to one or more parts of the breast.

Optional:

-   -   Breast pump system is wearable and the housing is shaped at        least in part to fit inside a bra.    -   The air chamber is a deformable diaphragm positioned on a breast        shield that attaches to the housing.

C. Elvie Milk Container Feature Cluster

Feature 29 Elvie is Wearable and Includes a Re-Useable, Rigid MilkContainer that Forms the Lower Part of the Pump, to Fit Inside a BraComfortably

A wearable breast pump system configured including:

(a) a housing shaped at least in part with a curved surface to fitinside a bra and including a pumping mechanism;

(b) and a re-useable rigid or non-collapsible milk container that whenconnected to the housing forms an integral, lower part of the housing,with a surface shaped to continue the curved shape of the housing, sothat the pump system can be held comfortably inside the bra.

Optional:

-   -   The milk container forms the base of the system.    -   The milk container has a flat base so that it can rest stably on        a surface.    -   The milk container is attached to the housing with a push        action.    -   The milk container includes a clear or transparent wall or        section to show the amount of milk collected.    -   The milk container is sealable for storage.    -   The milk container obviates the need for consumable or        replaceable milk pouches.    -   The milk container includes an aperture, spout or lid that sits        directly underneath an opening in a nipple tunnel of a breast        shield, and expressed milk flows under gravity through the        opening in the nipple tunnel and into the milk container.    -   The milk container includes an aperture, spout or lid that        self-seals under the negative air-pressure from the pumping        mechanism against an opening in a breast shield, and milk flows        under gravity through the opening into the milk container.    -   The milk container is made using a blow moulding construction.    -   The milk container has a large diameter opening to facilitate        cleaning that is at least 3 cm in diameter.    -   The large opening is closed with a bayonet-mounted cap with an        integral spout.    -   A flexible rubber or elastomeric valve is mounted onto the cap        or spout and includes a rubber or elastomeric duck-bill valve        that stays sealed when there is negative air-pressure being        applied by the air pump mechanism to ensure that negative        air-pressure is not applied to the milk container.    -   The pumping mechanism is a closed loop negative air-pressure        system that applies negative pressure to a region surrounding a        woman's breast to pump milk form that breast.

Feature 30 Elvie is Wearable and Includes a Milk Container that Latchesto the Housing with a Simple Push to Latch Action

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) and a milk container that is attachable to the housing with amechanism that releasably attaches or latches when the milk container issufficiently pressed on to the housing with a single push action.

Optional:

-   -   The milk container includes an aperture, spout or lid that        self-seals under the negative air-pressure from the pumping        mechanism against an opening in a breast shield, and milk flows        under gravity through the opening into the milk container.    -   Milk container, when connected to the housing, forms an        integral, lower part of the housing and that is removable from        the housing with a release mechanism that can be operated with        one hand.    -   Mechanism that releasably attaches or latches is a mechanical or        magnetic mechanism.    -   Mechanical mechanism includes flanges on the top of the milk        container, or the sealing plate that seals the opening to the        milk contained, that engage with and move past a surface to        occupy a latched position over that surface when the milk        container is pressed against the housing to lock into the        housing.    -   The housing includes a button that when pressed releases the        milk container from the housing by flexing the surface away from        the flanges so that the flanges no longer engage with and latch        against the surface.    -   Mechanism that attaches or latches the milk container into        position does so with an audible click.    -   The milk container forms the base of the system.    -   The milk container has a flat base so that it can rest stably on        a surface.    -   The milk container is removable from the housing by releasing        the latch and moving the housing off the milk container.    -   The milk container includes a clear or transparent wall or        section to show the amount of milk collected.    -   The milk container is sealable for storage.    -   The milk container obviates the need for consumable or        replaceable milk pouches.    -   The milk container includes an aperture that sits directly        underneath an opening in a nipple tunnel of a breast shield, and        expressed milk flows under gravity through the opening in the        nipple tunnel and into the milk container.    -   The milk container is made using a blow moulding construction.    -   The milk container has a large diameter opening to facilitate        cleaning that is at least 3 cm in diameter.    -   The large opening is closed with a bayonet-mounted cap with an        integral spout.    -   A flexible rubber or elastomeric valve is mounted onto the cap        or spout and includes a rubber or elastomeric duck-bill valve        that stays sealed when there is negative air-pressure being        applied by the air pump to ensure that negative air-pressure is        not applied to the milk container.    -   The pumping mechanism is a closed loop negative air-pressure        system that applies negative pressure to a region surrounding a        woman's breast to pump milk form that breast.

Feature 31 Elvie is Wearable and Includes a Removable Milk Containerwith an Integral Milk Pouring Spout for Convenience

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) and a re-useable milk container that is connected to the housingwith a surface shaped to continue the curved or breast-like shape of thepump, so that the pump can be held comfortably inside a bra and wherethe milk container includes a pouring spout for pouring milk.

Optional:

-   -   Spout is integral to the milk container.    -   Spout is integral to a removable lid to the milk container.    -   Spout is positioned at or close to the front edge of the milk        container.    -   Spout is removable from the container, such as by clipping off        the container.    -   A teat is attachable to the spout.    -   A flexible rubber or elastomeric valve is mounted onto the cap        or spout and includes a rubber or elastomeric duck-bill valve        that stays sealed when there is negative air-pressure being        applied by the air pump to ensure that negative air-pressure is        not applied to the milk container.    -   The milk container forms the base of the system.    -   The milk container has a flat base so that it can rest stably on        a surface.    -   The milk container is removable from the housing.    -   The milk container includes a clear or transparent wall or        section to show the amount of milk collected.    -   The milk container is sealable for storage.    -   The milk container obviates the need for consumable or        replaceable milk pouches.    -   The milk container includes an aperture that sits directly        underneath an opening in a nipple tunnel of a breast shield, and        expressed milk flows under gravity through the opening in the        nipple tunnel and into the milk container through the pouring        spout in the milk container.    -   The milk container includes an aperture, spout or lid that        self-seals under the negative air-pressure from the pumping        mechanism against an opening in a breast shield, and milk flows        under gravity through the opening into the milk container.    -   The milk container is made using a blow moulding construction.    -   The milk container has a large diameter opening to facilitate        cleaning that is at least 3 cm in diameter.    -   The large opening is closed with a bayonet-mounted cap with an        integral spout.    -   The pumping mechanism is a closed loop negative air-pressure        system that applies negative pressure to a region surrounding a        woman's breast to pump milk form that breast.

Feature 32 Elvie is Wearable and Includes a Removable Milk ContainerBelow the Milk Flow Path Defined by a Breast Shield for Fast andReliable Milk Collection

A wearable breast pump system including:

(a) a housing including a pumping mechanism, the housing being shaped atleast in part to fit inside a bra;

(b) and a breast shield including a nipple tunnel shaped to receive anipple, and including an opening that defines the start of a milk flowpath;

(c) a re-useable milk container that when connected to the housing ispositioned entirely below the opening or the milk flow path, when thebreast pump is positioned or oriented for normal use.

Optional:

-   -   The milk container includes an aperture that sits directly        underneath the opening in the nipple tunnel in the breast        shield, and expressed milk flows under gravity through the        opening in the nipple tunnel and into the milk container through        the pouring spout in the milk container.    -   Milk flows from the opening directly into the milk container.    -   Milk flows from the opening directly into the milk container.    -   The milk container includes an aperture, spout or lid that        self-seals under the negative air-pressure from the pumping        mechanism against the opening in the breast shield, and milk        flows under gravity through the opening into the milk container.    -   Milk flows from the opening directly onto a valve that is        attached to the milk container, the valve closing whilst there        is sufficient negative air pressure in the volume of air between        the valve and the breast shield opening, and then opening to        release the milk into the container when the air pressure rises        sufficiently.    -   Milk flows from the opening directly onto a valve that is        attached to a spout, that is in turn attached to the milk        container.    -   The milk container has a large diameter opening to facilitate        cleaning that is at least 3 cm in diameter.    -   The large opening is closed with a bayonet-mounted cap with an        integral spout.    -   A flexible rubber or elastomeric valve is mounted onto the milk        container cap or spout and includes a rubber or elastomeric        duck-bill valve that stays sealed when there is negative        air-pressure being applied by the air pump to ensure that        negative air-pressure is not applied to the milk container, and        milk flows towards and is retained by the duck bill valve whilst        the valve is closed, and flows past the valve into the milk        container when the negative air pressure is released and the        valve opens.    -   The breast shield and milk container are each pressed or pushed        into engagement with the housing.    -   The breast shield and milk container are each pressed or pushed        into a latched engagement with the housing.    -   The two removable parts are each insertable into and removable        from the housing using an action confirmed with an audible        sound, such as a click.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast and a nipple tunnel shaped        to receive a nipple.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around a        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Breast shield slides into the housing using guide members.    -   Housing is configured to slide onto the breast shield, when the        breast shield has been placed onto a breast, using guide        members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers, such as ball bearings in the housing locate        into small indents in the breast shield.    -   Breast shield latches into position against the housing using        magnets.

Feature 33 Elvie is Wearable and Includes a Breast Shield and RemovableMilk Container of Optically Clear, Dishwasher Safe Plastic for Ease ofUse and Cleaning

A breast pump system including:

(a) a housing including a pumping mechanism;

(b) and a breast shield defining a region shaped to receive a nipple,the region defining the start of a milk flow path;

(c) a re-useable, rigid or non-collapsible milk container that whenconnected to the housing is positioned to form the base of the housing;

-   -   and in which the breast shield and the milk container are made        substantially of an optically clear, dishwasher safe material.

Optional:

-   -   The material is a polycarbonate material, such as Tritan™.    -   breast pump system is wearable and the housing is shaped at        least in part to fit inside a bra.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast and a nipple tunnel shaped        to receive a nipple.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around a        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Breast shield operates with a flexible diaphragm that flexes        when negative air pressure is applied to it by an air pump        system in the housing, and transfers that negative air-pressure        to pull the breast and/or nipple against the breast shield to        cause milk to be expressed.    -   Flexible diaphragm is removable from a diaphragm housing portion        of the breast shield for cleaning.    -   Diaphragm housing includes an air hole that transfers negative        air pressure to a nipple tunnel in the breast shield, the        negative air pressure arising when the diaphragm moves away from        the diaphragm housing and towards the housing, and the negative        air pressure in the nipple tunnel pulling the breast and/or        nipple against the breast shield to cause milk to be expressed.    -   The breast shield and milk container are each pressed or pushed        into engagement with the housing.    -   The breast shield and milk container are each pressed or pushed        into a latched engagement with the housing.    -   The breast shield and milk container are each insertable into        and removable from the housing using an action confirmed with an        audible sound, such as a click.    -   The milk container includes an aperture, spout or lid that        self-seals under the negative air-pressure from the pumping        mechanism against an opening in a breast shield, and milk flows        under gravity through the opening into the milk container.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast and a nipple tunnel shaped        to receive a nipple.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around a        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Breast shield slides into the housing using guide members.    -   Housing is configured to slide onto the breast shield, when the        breast shield has been placed onto a breast, using guide        members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers, such as ball bearings in the housing locate        into small indents in the breast shield.    -   Breast shield latches into position against the housing using        magnets.

Feature 34 Elvie is Wearable and Includes Various Components thatSelf-Seal Under Negative Air Pressure, for Convenience of Assembly andDisassembly

A wearable breast pump system including:

(a) a housing shaped at least in part to fit inside a bra and includingan air pumping mechanism;

(b) a breast shield;

(c) a diaphragm that flexes in response to changes in air pressurecaused by the air pumping mechanism and that seals to the breast shield;

(d) a re-useable milk container that seals to the breast shield;

and in which either or both of the diaphragm and the re-useable milkcontainer substantially self-seal under the negative air pressureprovided by the pumping mechanism.

Optional:

-   -   The milk container includes an aperture, spout or lid that        self-seals under the negative air-pressure from the pumping        mechanism against an opening in a breast shield, and milk flows        under gravity through the opening into the milk container.    -   The re-useable milk container includes a 1 way valve that        self-seals against a conduit from the breast shield and allows        milk to pass into the container but not spill out, and in which        the valve (a) closes and (b) partly or wholly self-seals against        the conduit under the negative air pressure provided by the        pumping mechanism.    -   The 1 way valve is attached to the milk container, or a lid or        spout of the milk container with an interference fit and is        readily removed in normal use for separate cleaning.    -   The diaphragm partly or wholly self-seals to the breast shield        under the negative air pressure provided by the pumping        mechanism.    -   The diaphragm partly or wholly self-seals to the housing under        the negative air pressure provided by the pumping mechanism.    -   The diaphragm is attached to the diaphragm housing using        elastomeric or rubber latches and is readily removed in normal        use for separate cleaning.    -   The breast shield and milk container are each pressed or pushed        into engagement with the housing.    -   The breast shield and milk container are each pressed or pushed        into a latched engagement with the housing.    -   The breast shield and milk container are each insertable into        and removable from the housing using an action confirmed with an        audible sound, such as a click.    -   Breast shield is a one-piece item including a generally convex        surface shaped to fit over a breast and a nipple tunnel shaped        to receive a nipple.    -   Breast shield is generally symmetrical about a centre-line        running from the top to the bottom of the breast shield when        positioned upright for normal use.    -   Breast shield is configured to be rotated smoothly around a        nipple inserted into the nipple tunnel to position a diaphragm        housing portion of the breast shield at the top of the breast.    -   Breast shield slides into the housing using guide members.    -   Housing is configured to slide onto the breast shield, when the        breast shield has been placed onto a breast, using guide        members.    -   Breast shield latches into position against the housing.    -   Breast shield latches into position against the housing when        spring plungers, such as ball bearings in the housing locate        into small indents in the breast shield.    -   Breast shield latches into position against the housing using        magnets.

Feature 35 Elvie is Wearable and Includes a Spout at the Front Edge ofthe Milk Container for Easy Pouring

A wearable breast pump system configured as a single unit and including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) and a milk container that forms an integral part of the housing;

(c) a re-useable pouring spout that is positioned at or close to thefront edge of the milk container.

Optional:

-   -   Milk container is a multifunctional bottle, operating as both a        storage container to contain milk that is being expressed, as        well as a refrigeratable and freezable storage bottle for that        milk, as well as a bottle from which that milk can be drunk by a        baby.    -   Spout is integral to a removable lid to the milk container.    -   Spout is removable from the container, such as by clipping off        the container.    -   A teat is attachable to the spout.    -   By placing the spout at or close to the front edge of the milk        container, the milk container fully empties more readily than        where the spout is placed in the middle of the lid of a milk        container.    -   The spout sits generally under an opening in the breast shield        spout or nipple tunnel through which expressed milk flows.    -   The re-useable milk container includes a 1 way valve that        self-seals against a conduit from the breast shield and allows        milk to pass into the container but not spill out, and in which        the valve (a) closes and (b) partly or wholly self-seals against        the conduit under the negative air pressure provided by the        pumping mechanism.    -   The milk container includes an aperture, spout or lid that        self-seals under the negative air-pressure from the pumping        mechanism against an opening in a breast shield, and milk flows        under gravity through the opening into the milk container.

Feature 36 Elvie is Wearable and Includes a Milk Container that isShaped with Broad Shoulders and that can be Adapted as a Drinking Bottlethat Baby can Easily Hold

A wearable breast pump system configured as a single unit and including:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) a breast shield;

(c) a milk container that is removable from the housing and is shaped orconfigured to also serve as a drinking bottle that is readily held by ababy because it is wider than it is tall.

Optional:

-   -   Teat is attachable directly to the milk container.    -   Pouring or drinking spout is integral to the milk container.    -   The shoulders are at least 2 cm in width, and the neck is no        more than 1 cm in height, to enable a baby to readily grip and        hold the container when feeding from the milk in the container.    -   Spout/teat/straw resides near the edge of the container's rim.    -   Milk container is a multifunctional bottle, operating as both a        storage container to contain milk that is being expressed, as        well as a refrigeratable and freezable storage bottle for that        milk, as well as a bottle from which that milk can be drunk by a        baby.    -   The re-useable milk container includes a 1 way valve that        self-seals against a conduit from the breast shield and allows        milk to pass into the container but not spill out, and in which        the valve (a) closes and (b) partly or wholly self-seals against        the conduit under the negative air pressure provided by the        pumping mechanism.    -   The milk container includes an aperture, spout or lid that        self-seals under the negative air-pressure from the pumping        mechanism against an opening in a breast shield, and milk flows        under gravity through the opening into the milk container.    -   Spout is integral to the milk container.    -   Spout is integral to a removable lid to the milk container.    -   Spout is positioned at or close to the front edge of the milk        container.    -   Spout is removable from the container, such as by clipping off        the container.    -   A teat is attachable to the spout.    -   A flexible rubber or elastomeric valve is mounted onto the cap        or spout and includes a rubber or elastomeric duck-bill valve        that stays sealed when there is negative air-pressure being        applied by the air pump to ensure that negative air-pressure is        not applied to the milk container.    -   The milk container forms the base of the system.    -   The milk container has a flat base so that it can rest stably on        a surface.    -   The milk container is removable from the housing.    -   The milk container includes a clear or transparent wall or        section to show the amount of milk collected.    -   The milk container is sealable for storage.    -   The milk container obviates the need for consumable or        replaceable milk pouches.    -   The milk container includes an aperture that sits directly        underneath an opening in a nipple tunnel of a breast shield, and        expressed milk flows under gravity through the opening in the        nipple tunnel and into the milk container through the pouring        spout in the milk container.    -   The milk container is made using a blow moulding construction.    -   The milk container has a large diameter opening to facilitate        cleaning that is at least 3 cm in diameter.    -   The large opening is closed with a bayonet-mounted cap with an        integral spout.

D. Elvie IR System Feature Cluster

Feature 37 Elvie is Wearable and Includes a Light-Based System thatMeasures the Quantity of Milk in the Container for Fast and ReliableFeedback

A system for milk volume determination, for use as part of a breastpump, or breast milk collecting device, including:

(a) a re-useable rigid or non-collapsible milk container;

(b) at least one light emitter, configured to direct radiation towardsthe surface of the milk;

(c) at least one light detector, configured to detect reflectedradiation from the surface of the milk;

-   -   wherein the light emitters and detectors operate as part of a        sub-system that measures the height of, or infers the quantity        of, the milk in the container.

Optional:

The wearable breast pump system includes:

(a) a housing shaped at least in part to fit inside a bra and includinga pumping mechanism;

(b) and a breast shield;

(c) a re-useable rigid or non-collapsible milk container that whenconnected to the housing is positioned to form the base of the housing;

-   -   and in which the top of the container includes an optically        clear region that is aligned below one or more light emitters        positioned in the base of the housing.    -   The sub-system measures or infers the quantity and/or the height        of the liquid in the container by using one or more light        emitters and light detectors to detect light from the emitters        that has been reflected by the liquid, and measuring the        intensity of that reflected light.    -   Sub-system includes an accelerometer and uses a signal from the        accelerometer to determine if the liquid is sufficiently still        to permit the sub-system to accurately measure or infer the        quantity and/or the height of the liquid in the container.    -   The sub-system measures or infers the quantity and/or the height        of the liquid in the container and shares that data with a data        connectivity module.    -   Where the quantity or level exceeds a threshold, then the        pumping mechanism automatically changes mode, e.g. from a        stimulation mode to an expression mode.    -   Where the quantity or level exceeds a threshold, then the        pumping mechanism automatically stops.    -   Milk-flow data is captured and stored.    -   If milk-flow falls below a threshold, then a notification is        provided to the mother.

Feature 38 the Separate IR Puck for Liquid Quantity Measurement

A liquid-level measuring system for measuring the quantity of liquid ina container for a breast pump; the system including:

(a) one or more light emitters directing light at the surface of theliquid in the container;

(b) one or more light receivers configured to detect light from thelight emitters that has been reflected from the liquid;

(c) a sub-system that infers, measures or calculates the quantity in theliquid using measured properties of the detected light;

(d) a collar or other fixing system that positions the system over thecontainer.

Optional:

-   -   The quantity of milk is measured as milk enters the container or        as milk is removed from the container.    -   Measured property includes the reflected light intensity

Feature 39 the Separate IR Puck Combined with Liquid Tilt AngleMeasurement

A liquid-level measuring system for measuring the tilt angle of liquidin a container; the system including:

(a) one or more light emitters directing light at the surface of theliquid in the container;

(b) one or more light receivers configured to measure properties of thelight reflected from the liquid;

(c) a sub-system including an accelerometer that infers, measures orcalculates the tilt angle of the liquid using measured properties of thedetected light;

(d) a collar or other fixing system that positions the system over thecontainer.

Optional:

-   -   Measured property includes the reflected light intensity    -   The quantity of liquid is measured as liquid enters the        container or as liquid is removed from the container.    -   Sub-system includes an accelerometer and uses a signal from the        accelerometer to determine if the liquid is sufficiently still        to permit the sub-system to accurately measure or infer the        quantity and/or the height of the liquid in the container.    -   The sub-system measures or infers the quantity and/or the height        of the liquid in the container and shares that data with a data        connectivity module.

Generally Applicable Optional Features

-   -   Weight of the entire unit, unfilled, is under 250 g and        preferably 214 g.    -   Silver based bactericide is used on all parts that are not steam        or heat sterilized in normal cleaning.    -   Housing includes a rechargeable battery.    -   System is self-contained.    -   System is a closed loop system.    -   Breast pump system is a self-contained, wearable device that        includes an integral rechargeable battery, control electronics,        and one or more air pumps operating as a closed system, driving        a flexible diaphragm that in turn delivers negative air-pressure        to the breast, to cause milk to be expressed.    -   Housing has a generally rounded or convex front surface and has        a generally tear-drop shape when seen from the front.

E. Bra Clip Feature Cluster

Feature 40 Bra Adjuster

A bra adjuster for a nursing or maternity bra, the nursing or maternitybra including a bra cup with a flap that can be undone to expose thenipple, and the flap attaching to the shoulder strap using a clasp, hookor other fastener attached to the flap, and a corresponding fastenerattached to the shoulder strap;

-   -   and in which the bra adjuster is attachable at one end to the        fastener attached to the flap, and at its other end to the        fastener attached to the shoulder strap, and hence increases the        effective bra cup size sufficiently to accommodate a wearable        breast pump, and is also detachable from the flap and shoulder        strap.

Optional:

-   -   Bra adjuster is retained in position on the bra during normal        wearing of the bra, even when the flap is attached directly to        the shoulder strap, and is used to increases the effective bra        cup size only when the wearable breast pump is used.    -   Bra adjuster is extensible or elastic.    -   Bra adjuster is of a fixed length.    -   Bra adjuster includes a clip that the user can slide onto the        bra strap to secure the bra adjuster in position.    -   Bra adjuster is machine-washing washable.

F. Other Features that can Sit Outside the Breast Pump Context

Feature 41 Wearable Device Using More than One Piezo Pump Connected inSeries or in Parallel

A wearable device including multiple piezo pumps mounted together eitherin series or in parallel.

Optional:

-   -   The wearable device is a medical wearable device.    -   The piezo pumps air or any liquid etc.    -   The system can switch between a parallel mode and a series mode        to arrive to lower or higher pressure quicker.

Feature 42 Wearable Medical Device Using a Piezo Pump and a Heat SinkAttached Together.

A wearable medical device including a piezo pump and a heat sinkattached together.

Optional

-   -   The wearable device uses more than one piezo pump connected in        series.    -   The wearable device uses more than one piezo pump connected in        parallel.    -   Each piezo pump is connected to its own heat sink, or to a        common heat sink.    -   The or each heat sink is configured to ensure that the maximum        temperature of any parts of the breast pump system that might        come into contact with the skin, especially prolonged contact        for greater than 1 minute, are no more than 48° C. and        preferably no more than 43° C.    -   The wearable device includes a thermal cut out.    -   Excess heat is diverted to a specific location on the device        that is selected to not be in prolonged contact with the skin of        the user, in normal use.    -   Use cases application:        -   Wound therapy        -   High degree burns        -   Sleep apnea        -   Deep vein thrombosis        -   Sports injury.    -   Wearable medical device is powered/charged via USB.

Note

It is to be understood that the above-referenced arrangements are onlyillustrative of the application for the principles of the presentinvention. Numerous modifications and alternative arrangements can bedevised without departing from the spirit and scope of the presentinvention. While the present invention has been shown in the drawingsand fully described above with particularity and detail in connectionwith what is presently deemed to be the most practical and preferredexample(s) of the invention, it will be apparent to those of ordinaryskill in the art that numerous modifications can be made withoutdeparting from the principles and concepts of the invention as set forthherein.

The invention claimed is:
 1. A breast pump device that is configured asa self-contained, in-bra wearable device, the breast pump devicecomprising: a housing that includes: a battery, and a pump powered bythe battery and generating negative air pressure; a breast shield madeup of a breast flange and a nipple tunnel; a milk container that isconfigured to be attached to and removed from the housing; and adiaphragm configured to be seated against a diaphragm holder that formsa recess or cavity at least in part with an external surface of thehousing, the diaphragm deforming in response to changes in air pressurecaused by the pump to create negative air pressure in the nipple tunnel.2. The breast pump device of claim 1, wherein the pump comprises a piezoair pump system.
 3. The breast pump device of claim 1, wherein the pumpis positioned at or close to a base of the housing.
 4. The breast pumpdevice of claim 1, wherein a total mass of the breast pump device,unfilled with milk, is less than 250 gm.
 5. The breast pump device ofclaim 1, wherein the breast pump device makes less than 30 dB noise atmaximum power and less than 25 dB at normal power, against a 20 dBambient noise.
 6. The breast pump device of claim 1, wherein the breastshield is substantially rigid.
 7. The breast pump device of claim 1,wherein the breast shield is configured to rotate smoothly around anipple inserted into the nipple tunnel to provide a correct positioningof the breast shield onto a breast.
 8. The breast pump device of claim1, wherein the breast shield is a one piece item that, in use, presentsa single continuous surface to a nipple and a breast.
 9. The breast pumpdevice of claim 1, wherein the breast shield integrates the breastflange and nipple tunnel as a one-piece item.
 10. The breast pump deviceof claim 1, wherein the breast flange and the nipple tunnel are asingle, integral item with no joining stubs.
 11. The breast pump deviceof claim 1, wherein the breast shield is generally symmetrical about acentre-line running from a top to a bottom of the breast shield whenpositioned upright for normal use.
 12. The breast pump device of claim1, wherein the housing is configured to slide onto the breast shield,when the breast shield has been placed onto a breast, using guidemembers.
 13. The breast pump device of claim 1, wherein the breast pumpdevice includes only the breast shield and the milk container that aredirectly removable from the housing in normal use or normaldis-assembly.
 14. The breast pump device of claim 1, wherein thediaphragm is a flexible membrane.
 15. The breast pump device of claim 1,wherein the diaphragm is substantially circular and is configured toself-seal under the negative air pressure to a substantially circulardiaphragm holder that is part of the housing.
 16. The breast pump deviceof claim 1, wherein the milk container is substantially rigid.
 17. Thebreast pump device of claim 1, wherein the milk container is configuredto attach to a lower part of the housing and to form a flat bottomedbase for the breast pump device.
 18. The breast pump device of claim 1,wherein the milk container has a surface shaped to continue a curvedshape of the housing, so that the breast pump device can be heldcomfortably inside the bra.
 19. The breast pump device of claim 1,wherein the milk container includes a flexible valve that self-sealsunder negative air pressure against a milk opening in the nipple tunneland that permits milk to flow into the milk container.
 20. The breastpump device of claim 1, wherein the milk container is attachable to thehousing with a mechanical or magnetic mechanism that releasably attachesor latches when the milk container is sufficiently pressed on to thehousing with a single push action.
 21. The breast pump device of claim1, wherein the milk container includes a cap that is removable from themilk container and a removable valve that enables milk to pass into themilk container in one direction.
 22. The breast pump device of claim 1,wherein a top of the milk container includes an optically clear regionthat is aligned below one or more light emitters positioned in a base ofthe housing.
 23. The breast pump device of claim 1, wherein the milkcontainer is wider than the milk container is tall.
 24. The breast pumpdevice of claim 1, wherein the housing includes a wireless datacommunications system powered by the battery.
 25. The breast pump deviceof claim 1, wherein the housing has a front surface that is configuredto fit inside a bra and to contact an inner surface of the bra, and arear surface that is shaped to contact, at least in part, the breastshield.
 26. The breast pump device of claim 1, wherein the housingincludes at least one of a visual or haptic indicator that indicateswhether milk is flowing or not flowing into the milk container.
 27. Thebreast pump device of claim 1, wherein the housing includes at least oneof a visual or haptic indicator that indicates if the pump is operatingcorrectly to pump milk, based on whether a quantity or a height ofliquid in the milk container above a base of the milk container isincreasing above a threshold rate of increase.
 28. The breast pumpdevice of claim 1, wherein the battery is a rechargeable battery, andthe housing further includes: a power charging circuit for controllingthe charging of the rechargeable battery, and control electronicspowered by the rechargeable battery.